Lower risk Medical device recall · FDA · Published May 10, 2023
Medtronic ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL: Rare reduced energy output during high
Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL with serial numbers listed.
Lower-risk recall
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Contact the company
Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
What happened, in plain English
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may have a glassed feedthrough causing reduced or no energy output during high voltage therapy. This rare issue could affect device function but does not pose an immediate risk to users. Read more at govinfonow.com/recall/58323-medtronic-icd-dr-ddbb2d1-evera-xt-is1-df1-intl-rare.
Source Summary by GovInfoNow · govinfonow.com/recall/58323-medtronic-icd-dr-ddbb2d1-evera-xt-is1-df1-intl-rare · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1707-2023
Cite this page
“Medtronic ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL: Rare reduced energy output during high.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58323-medtronic-icd-dr-ddbb2d1-evera-xt-is1-df1-intl-rare. Based on FDA recall #Z-1707-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1707-2023%22&limit=1).
Why it’s dangerous
The device uses a glassed feedthrough that may cause reduced or no energy output during high voltage therapy (typically 0-12J). This could lead to the device failing to deliver necessary shocks during critical heart rhythm events, but the risk is rare and not immediate.
Who’s affected
People with Medtronic ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. Most users are not at risk as this is a rare issue.
How to tell if you have this one
Check if your device has the model number DDBB2D1 and serial numbers listed in the recall (e.g., BWE613480S, BWE613110S, etc.). The device is an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
- Brand
Medtronic- Product
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators- Category
Medical device
All 120 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
US Nationwide - Worldwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1704-2023 | ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169720404, Lot Serial Numbers: BWC242988H, BWC241999H, BWC242338H, BWC242392H, BWC243112H, BWC243417H, BWC243633H, BWC243786H, BWC244004H, BWC241880H, BWC242816H, BWC243834H, BWC241861H, BWC242999H, BWC241742H, BWC241891H, BWC241930H, BWC242022H, BWC242027H, BWC242157H, BWC242236H, BWC242463H, BWC242464H, BWC242466H, BWC242482H, BWC242567H, BWC242583H, BWC242645H, BWC242697H, BWC242718H, BWC242721H, BWC242804H, BWC242997H, BWC243009H, BWC243043H, BWC243095H, BWC243211H, BWC243216H, BWC243245H, BWC243258H, BWC243378H, BWC243488H, BWC243489H, BWC243590H, BWC243657H, BWC243711H, BWC243743H, BWC243863H, BWC244033H, BWC244161H, BWC244282H, BWC244431H, BWC242166H, BWC242897H, BWC243484H, BWC243570H, BWC244218H, BWC244438H, BWC241690H, BWC242739H, BWC243166H, BWC243372H, BWC243918H, BWC241761H, BWC243769H, BWC241692H, BWC242218H, BWC242258H, BWC242430H, BWC242496H, BWC242627H, BWC243113H, BWC243183H, BWC243398H, BWC243422H, BWC243536H, BWC243559H, BWC244411H, BWC244490H, BWC242381H, BWC243436H, BWC244026H, BWC243607H, BWC241926H, BWC241948H, BWC241974H, BWC242093H, BWC242228H, BWC242252H, BWC242403H, BWC242418H, BWC242691H, BWC242815H, BWC243736H, BWC244061H, BWC244445H, BWC243128H, BWC243679H, BWC243790H… Full codes in the FDA record | 2179 units |
| Z-1705-2023 | ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720374, Lot Serial Numbers: BWB231977H, BWB232204H, BWB231981H, BWB231888H, BWB232232H, BWB232076H, BWB231876H, BWB231908H, BWB231979H, BWB232244H, BWB232310H, BWB231918H, BWB232114H, BWB231867H, BWB232361H, BWB231879H, BWB231847H, BWB232311H, BWB232048H, BWB231915H, BWB232272H, BWB232281H, BWB232164H, BWB232142H, BWB232316H, BWB232027H, BWB232321H, BWB231976H, BWB232046H, BWB232357H, BWB232185H, BWB232233H, BWB232334H, BWB232378H, BWB232411H, BWB232049H, BWB232218H, BWB232097H, BWB232326H, BWB232156H, BWB231855H, BWB231858H, BWB232032H, BWB232106H, BWB232015H, BWB232260H, BWB232284H, BWB232328H, BWB232059H, BWB232018H, BWB232037H, BWB232043H, BWB232092H, BWB232112H, BWB232125H, BWB232144H, BWB232175H, BWB232179H, BWB232181H, BWB232190H, BWB232216H, BWB232237H, BWB232340H, BWB232369H, BWB232410H, BWB232414H, BWB231927H, BWB232056H, BWB232071H, BWB232087H, BWB232121H, BWB232250H, BWB232403H, BWB232039H, BWB232123H, BWB232124H, BWB231865H, BWB232128H, BWB232152H, BWB231939H, BWB231999H, BWB232050H, BWB232217H, BWB232298H, BWB232368H, BWB232395H, BWB232222H, BWB232174H, BWB231916H, BWB231963H, BWB231965H, BWB231968H, BWB232084H, BWB232154H, BWB232320H, BWB232393H, BWB232396H, BWB232399H, BWB232400H… Full codes in the FDA record | 522 units |
| Z-1706-2023 | ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators; GTIN 00643169518216, Lot Serial Numbers: BWB232002H | 1 unit |
| Z-1707-2023 | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169217911, Lot Serial Numbers: BWE613480S, BWE613110S, BWE613432S, BWE613202S, BWE613100S, BWE613096S, BWE613185S, BWE613258S, BWE613431S, BWE612802S, BWE612865S, BWE613214S, BWE613235S, BWE612884S, BWE612956S, BWE613098S, BWE613122S, BWE613143S, BWE613171S, BWE613212S, BWE613216S, BWE613251S, BWE613470S, BWE613162S, BWE613238S, BWE613459S, BWE613430S, BWE613153S, BWE613484S, BWE613168S, BWE612948S, BWE612950S, BWE612970S, BWE613487S, BWE613090S, BWE613224S, BWE613180S, BWE613077S, BWE612815S, BWE612940S, BWE613086S, BWE612721S, BWE613194S, BWE612880S, BWE613125S, BWE613221S, BWE612822S, BWE612985S, BWE612928S, BWE613446S, BWE612939S, BWE612837S, BWE613097S, BWE613095S, BWE613104S, BWE613211S, BWE613463S, BWE613460S, BWE612679S, BWE612960S, BWE613149S, BWE613150S, BWE613247S, BWE612981S, BWE612987S, BWE613145S, BWE613147S, BWE613485S, BWE612986S, BWE613443S, BWE612844S, BWE612686S, BWE612824S, BWE612853S, BWE612923S, BWE612976S, BWE612935S, BWE612982S, BWE612993S, BWE613155S, BWE613124S, BWE612930S, BWE612949S, BWE612833S, BWE613115S, BWE613182S, BWE613121S, BWE612922S, BWE612990S, BWE613197S, BWE612801S, BWE612988S, BWE613111S, BWE613116S, BWE613146S, BWE613183S, BWE613352S, BWE613141S, BWE613466S… Full codes in the FDA record | 2282 units |
| Z-1708-2023 | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169217928, Lot Serial Numbers: BWD609356S, BWD609450S, BWD609318S, BWD609387S, BWD609454S, BWD609558S, BWD609464S, BWD609549S, BWD609355S, BWD609467S, BWD609389S, BWD609343S, BWD609397S, BWD609567S, BWD609395S, BWD609462S, BWD609470S, BWD609316S, BWD609554S, BWD609551S, BWD609594S, BWD609391S, BWD609466S, BWD609560S, BWD609473S, BWD609288S, BWD609322S, BWD609352S, BWD609360S, BWD609465S, BWD609476S, BWD609547S, BWD609363S, BWD609472S, BWD609573S, BWD609319S, BWD609526S, BWD609570S, BWD609448S, BWD609370S, BWD609320S, BWD609367S, BWD609317S, BWD609368S, BWD609371S, BWD609385S, BWD609362S, BWD609373S, BWD609381S, BWD609346S, BWD609574S, BWD609572S, BWD609365S, BWD609357S, BWD609348S, BWD609451S, BWD609568S, BWD609386S, BWD609344S, BWD609468S, BWD609559S, BWD609569S, BWD609342S, BWD609347S, BWD609353S, BWD609566S, BWD609374S, BWD609453S, BWD609361S, BWD609459S, BWD609460S, BWD609392S, BWD609553S, BWD609562S, BWD609359S, BWD609345S, BWD609366S, BWD609384S, BWD609455S, BWD609399S, BWD609354S, BWD609461S, BWD609403S, BWD609388S, BWD609321S, BWD609458S, BWD609351S, BWD609545S; GTIN 00643169969551, Lot Serial Numbers: BWD609418S, BWD609419S, BWD609420S, BWD609421S, BWD609422S, BWD609423S, BWD609424S… Full codes in the FDA record | 727 units |
| Z-1709-2023 | ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H, BWG208224H, BWG208225H, BWG208258H, BWG208261H, BWG208272H, BWG208275H, BWG208276H, BWG208279H, BWG208328H, BWG208337H, BWG208343H, BWG208357H, BWG208360H, BWG208361H, BWG208416H, BWG208417H, BWG208422H, BWG208423H, BWG208462H… Full codes in the FDA record | 5176 units |
| Z-1710-2023 | ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H, BWF206417H, BWF206424H, BWF206476H, BWF206539H, BWF206580H, BWF206485H, BWF206608H, BWF206601H, BWF206317H, BWF206384H, BWF206395H, BWF206490H, BWF206585H, BWF206590H, BWF206322H, BWF206431H, BWF206443H, BWF206463H, BWF206484H… Full codes in the FDA record | 4056 units |
| Z-1711-2023 | ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA230660H, CWA212204H, CWA215507H, CWA219655H, CWA228049H, CWA228101H, CWA230635H, CWA230642H, CWA213967H, CWA217145H, CWA220168H, CWA225093H, CWA229346H, CWA232234H, CWA215257H, CWA215420H, CWA221756H, CWA221922H, CWA222159H, CWA225001H, CWA225149H, CWA225777H, CWA227620H, CWA227845H, CWA228935H, CWA229962H, CWA231576H, CWA231578H, CWA213741H, CWA216957H, CWA223516H, CWA225894H, CWA231485H, CWA211463H, CWA211464H, CWA211465H, CWA211466H, CWA211467H, CWA211468H, CWA211470H, CWA214199H, CWA214200H, CWA214201H, CWA214203H, CWA214205H, CWA214208H, CWA214210H, CWA214211H, CWA214212H, CWA214213H, CWA217480H, CWA217481H, CWA217482H, CWA217483H, CWA217484H, CWA217485H, CWA220397H, CWA220400H, CWA220407H, CWA220408H, CWA222904H, CWA224042H, CWA226903H, CWA226919H, CWA230608H, CWA230609H, CWA230611H, CWA230612H, CWA217020H, CWA220851H, CWA224216H, CWA226111H, CWA230832H, CWA231351H, CWA220280H, CWA222986H, CWA223614H, CWA229484H, CWA218262H, CWA224443H, CWA212537H, CWA213744H, CWA214146H, CWA214362H, CWA215549H, CWA215657H, CWA216424H, CWA216460H, CWA216476H, CWA217621H, CWA217808H, CWA217987H, CWA218225H… Full codes in the FDA record | 22484 units |
| Z-1712-2023 | ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720497, Lot Serial Numbers: PFZ236436H, PFZ242339H, PFZ247708H, PFZ247891H, PFZ250783H, PFZ252117H, PFZ259560H, PFZ265053H, PFZ271895H, PFZ248688H, PFZ254957H, PFZ260373H, PFZ273832H, PFZ244136H, PFZ245315H, PFZ264212H, PFZ271087H, PFZ273388H, PFZ238454H, PFZ242886H, PFZ245032H, PFZ245482H, PFZ251539H, PFZ251620H, PFZ254361H, PFZ256071H, PFZ258481H, PFZ259582H, PFZ261497H, PFZ263430H, PFZ264999H, PFZ268418H, PFZ269828H, PFZ274151H, PFZ236422H, PFZ239293H, PFZ240140H, PFZ242722H, PFZ244519H, PFZ244850H, PFZ246467H, PFZ247093H, PFZ248638H, PFZ250072H, PFZ250429H, PFZ251666H, PFZ263854H, PFZ268573H, PFZ268973H, PFZ240263H, PFZ242174H, PFZ247965H, PFZ263650H, PFZ268685H, PFZ270530H, PFZ240280H, PFZ240282H, PFZ240283H, PFZ240284H, PFZ240285H, PFZ240286H, PFZ240287H, PFZ240288H, PFZ240292H, PFZ240294H, PFZ240295H, PFZ240296H, PFZ245429H, PFZ245430H, PFZ245435H, PFZ245437H, PFZ253305H, PFZ253306H, PFZ253312H, PFZ253315H, PFZ253317H, PFZ253318H, PFZ256364H, PFZ256365H, PFZ256366H, PFZ256367H, PFZ256368H, PFZ256371H, PFZ257391H, PFZ261794H, PFZ270374H, PFZ271142H, PFZ271143H, PFZ236326H, PFZ236764H, PFZ237716H, PFZ238433H, PFZ243679H, PFZ244764H, PFZ246310H, PFZ246566H, PFZ246737H, PFZ247439H… Full codes in the FDA record | 61,404 units |
| Z-1713-2023 | ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB601945S, CWB601946S, CWB602803S, CWB605225S, CWB607387S, CWB609714S, CWB605552S, CWB601729S, CWB602371S, CWB603105S, CWB603660S, CWB603852S, CWB604726S, CWB605271S, CWB608325S, CWB609120S, CWB607821S, CWB607823S, CWB607829S, CWB607834S, CWB607881S, CWB607884S, CWB607885S, CWB607886S, CWB608671S, CWB608672S, CWB608675S, CWB608676S, CWB608677S, CWB608678S, CWB608680S, CWB608681S, CWB608683S, CWB608684S, CWB608686S, CWB608687S, CWB608690S, CWB608691S, CWB608692S, CWB608697S, CWB609222S, CWB609930S, CWB609931S, CWB607959S, CWB608041S, CWB608051S, CWB608052S, CWB608055S, CWB608064S, CWB608067S, CWB608068S, CWB608069S, CWB608073S, CWB608074S, CWB608075S, CWB608081S, CWB608084S, CWB608085S, CWB608088S, CWB608089S, CWB608095S, CWB608842S, CWB608843S, CWB608844S, CWB608845S, CWB608847S, CWB608848S, CWB608849S, CWB608851S, CWB608854S, CWB608855S, CWB608856S, CWB608857S, CWB608858S, CWB608859S, CWB608861S, CWB608862S, CWB608863S, CWB606447S, CWB606663S, CWB609802S, CWB607230S, CWB608732S, CWB608748S, CWB607378S, CWB607380S, CWB607395S, CWB607440S, CWB607442S, CWB610021S, CWB610035S, CWB607236S, CWB607237S… Full codes in the FDA record | 8626 units |
| Z-1714-2023 | ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169443419, Lot Serial Numbers: PGZ624363S, PGZ631078S, PGZ638449S, PGZ638465S, PGZ623851S, PGZ645877S, PGZ621671S, PGZ621673S, PGZ623094S, PGZ623561S, PGZ623984S, PGZ623985S, PGZ623986S, PGZ623991S, PGZ624447S, PGZ626933S, PGZ626995S, PGZ627005S, PGZ627071S, PGZ629198S, PGZ629204S, PGZ629217S, PGZ631034S, PGZ631035S, PGZ631036S, PGZ631037S, PGZ633073S, PGZ633357S, PGZ633680S, PGZ635203S, PGZ635731S, PGZ635749S, PGZ635812S, PGZ635815S, PGZ635820S, PGZ637440S, PGZ637885S, PGZ637919S, PGZ637947S, PGZ637950S, PGZ638090S, PGZ638096S, PGZ638463S, PGZ641070S, PGZ641071S, PGZ641072S, PGZ641083S, PGZ641140S, PGZ641168S, PGZ641651S, PGZ641687S, PGZ642430S, PGZ643962S, PGZ645328S, PGZ622752S, PGZ626967S, PGZ629552S, PGZ630964S, PGZ631210S, PGZ632646S, PGZ637386S, PGZ641102S, PGZ643196S, PGZ644010S, PGZ629356S, PGZ632534S, PGZ636328S, PGZ636330S, PGZ637349S, PGZ638180S, PGZ638396S, PGZ641545S, PGZ641547S, PGZ623932S, PGZ624470S, PGZ629461S, PGZ630997S, PGZ631127S, PGZ636208S, PGZ638240S, PGZ640023S, PGZ641657S, PGZ641677S, PGZ632771S, PGZ630319S, PGZ637994S, PGZ622780S, PGZ622781S, PGZ624036S, PGZ627292S, PGZ628782S, PGZ629050S, PGZ631254S, PGZ633614S, PGZ638098S, PGZ638275S, PGZ638285S, PGZ640025S… Full codes in the FDA record | 35,961 units |
| Z-1715-2023 | ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC608108S, CWC607103S, CWC601544S, CWC601546S, CWC605273S, CWC602965S, CWC604941S, CWC605039S, CWC601687S, CWC601688S, CWC602560S, CWC602845S, CWC603176S, CWC603372S, CWC603584S, CWC603596S, CWC603780S, CWC603826S, CWC603862S, CWC604054S, CWC604145S, CWC604909S, CWC605061S, CWC605800S, CWC607271S, CWC607272S, CWC607475S, CWC608775S, CWC608917S, CWC608956S, CWC608480S, CWC608488S, CWC603831S, CWC604086S, CWC604166S, CWC604240S, CWC604391S, CWC604670S, CWC604681S, CWC604684S, CWC604846S, CWC604847S, CWC605090S, CWC605290S, CWC605410S, CWC605411S, CWC605588S, CWC605600S, CWC605863S, CWC605864S, CWC605867S, CWC605876S, CWC605988S, CWC605989S, CWC606354S, CWC606357S, CWC606358S, CWC606521S, CWC606523S, CWC606525S, CWC606527S, CWC606528S, CWC606529S, CWC606531S, CWC606939S, CWC606942S, CWC607001S, CWC607022S, CWC607619S, CWC607630S, CWC607631S, CWC607635S, CWC604643S, CWC605193S, CWC605519S, CWC605785S, CWC606634S, CWC606664S, CWC606904S, CWC606912S, CWC607065S, CWC605675S, CWC605681S, CWC606623S, CWC606625S, CWC606627S, CWC606630S, CWC606675S, CWC606903S, CWC606905S, CWC606907S, CWC606622S, CWC602509S… Full codes in the FDA record | 10,903 units |
| Z-1716-2023 | ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, PHZ205207H, PHZ205208H, PHZ205209H, PHZ205210H, PHZ205211H, PHZ205213H, PHZ205216H, PHZ205244H, PHZ202741H, PHZ203347H, PHZ202606H, PHZ202985H, PHZ203618H, PHZ204288H, PHZ205146H, PHZ202758H, PHZ202806H, PHZ203203H, PHZ203252H, PHZ203313H, PHZ203319H, PHZ203321H, PHZ203702H, PHZ203771H, PHZ204242H, PHZ204399H, PHZ204603H, PHZ204771H, PHZ204983H, PHZ204987H, PHZ205118H, PHZ205301H, PHZ205302H, PHZ202654H, PHZ202763H… Full codes in the FDA record | 37,547 units |
| Z-1717-2023 | ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators; GTIN 00763000001483, Lot Serial Numbers: CWM603134S, CWM600439S, CWM601269S, CWM603840S, CWM603922S, CWM601037S, CWM602990S, CWM603292S, CWM602888S, CWM602567S, CWM604350S, CWM604400S, CWM604147S, CWM604447S, CWM603919S, CWM604293S, CWM603993S, CWM604453S, CWM604276S, CWM603779S, CWM603512S, CWM604434S, CWM604110S, CWM603974S, CWM604303S, CWM604451S, CWM604296S, CWM603643S, CWM604349S, CWM603935S, CWM603697S, CWM603897S, CWM604404S, CWM603551S, CWM601796S, CWM601798S, CWM601800S, CWM601801S, CWM601802S, CWM601905S, CWM601911S, CWM601931S, CWM602000S, CWM602003S, CWM602004S, CWM602005S, CWM602006S, CWM602097S, CWM602098S, CWM602124S, CWM602139S, CWM602709S, CWM602710S, CWM602711S, CWM602823S, CWM602836S, CWM602838S, CWM602847S, CWM602848S, CWM602883S, CWM602898S, CWM603276S, CWM600958S, CWM601164S, CWM601353S, CWM601410S, CWM601640S, CWM601831S, CWM602141S, CWM603581S, CWM603582S, CWM603627S, CWM603628S, CWM604291S, CWM604292S, CWM601211S, CWM601263S, CWM601339S, CWM601506S, CWM601641S, CWM601775S, CWM601830S, CWM601834S, CWM601838S, CWM601839S, CWM601969S, CWM601974S, CWM601975S, CWM601982S, CWM602156S, CWM602313S, CWM602566S, CWM602573S, CWM602580S, CWM602662S, CWM602663S, CWM602864S, CWM602921S, CWM603097S, CWM603100S… Full codes in the FDA record | 3801 units |
| Z-1718-2023 | ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators; GTIN 00763000001506, Lot Serial Numbers: CWN606940S, CWN606941S, CWN606806S, CWN609866S, CWN607173S, CWN607174S, CWN606850S, CWN605016S, CWN605224S, CWN605226S, CWN602473S, CWN605696S, CWN606066S, CWN601517S, CWN610794S, CWN611698S, CWN611709S, CWN611042S, CWN611699S, CWN608530S, CWN611057S, CWN611194S, CWN611137S, CWN611173S, CWN611168S, CWN610989S, CWN610994S, CWN610999S, CWN608676S, CWN610063S, CWN608932S, CWN609322S, CWN610602S, CWN608143S, CWN610351S, CWN611528S, CWN611651S, CWN607995S, CWN611583S, CWN608694S, CWN611439S, CWN611468S, CWN611541S, CWN611395S, CWN608844S, CWN611563S, CWN611417S, CWN608827S, CWN608184S, CWN608185S, CWN607983S, CWN609341S, CWN612034S, CWN610308S, CWN609462S, CWN608691S, CWN611586S, CWN611558S, CWN611650S, CWN611477S, CWN611385S, CWN611576S, CWN608837S, CWN608405S, CWN610408S, CWN611574S, CWN611547S, CWN611599S, CWN611554S, CWN603401S, CWN603403S, CWN603404S, CWN603405S, CWN603407S, CWN603408S, CWN603409S, CWN603516S, CWN603517S, CWN603518S, CWN603521S, CWN603779S, CWN603780S, CWN603785S, CWN603786S, CWN603944S, CWN603945S, CWN603955S, CWN603965S, CWN604184S, CWN604203S, CWN604223S, CWN604232S, CWN605362S, CWN605449S, CWN605556S, CWN605559S, CWN605561S, CWN605562S, CWN605577S, CWN605624S… Full codes in the FDA record | 11,239 units |
| Z-1719-2023 | ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators; GTIN 00763000001568, Lot Serial Numbers: CWS603181S, CWS601328S, CWS601620S, CWS601980S, CWS602302S, CWS602482S, CWS602880S, CWS602742S, CWS602559S, CWS602607S, CWS602433S, CWS602957S, CWS601056S, CWS601348S, CWS601807S, CWS602219S, CWS602422S, CWS602474S, CWS601519S, CWS601425S, CWS601296S, CWS602918S, CWS600483S, CWS600490S, CWS600494S, CWS600607S, CWS600960S, CWS601001S, CWS601199S, CWS601460S, CWS601594S, CWS601704S, CWS601713S, CWS601790S, CWS600422S, CWS600502S, CWS600125S, CWS600132S, CWS600342S, CWS600571S, CWS601791S, CWS600172S, CWS600318S, CWS600423S, CWS600453S, CWS600464S, CWS600686S, CWS601122S, CWS601155S, CWS601445S, CWS601981S, CWS601465S, CWS601628S, CWS600445S, CWS602676S, CWS600945S, CWS600142S, CWS600147S, CWS600178S, CWS600551S, CWS600557S, CWS600770S, CWS600996S, CWS601094S, CWS601323S, CWS601966S, CWS602181S, CWS602556S, CWS602618S, CWS602879S, CWS601541S, CWS601542S, CWS601203S, CWS601374S, CWS602139S, CWS600458S, CWS600102S, CWS600781S, CWS600759S, CWS600764S, CWS600765S, CWS600805S, CWS600806S, CWS600807S, CWS601024S, CWS601111S, CWS601201S, CWS601718S, CWS601979S, CWS602753S, CWS600731S, CWS601304S, CWS601780S, CWS602108S, CWS602214S, CWS601240S, CWS602411S, CWS602889S, CWS600108S, CWS601150S… Full codes in the FDA record | 2831 units |
| Z-1720-2023 | ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators; GTIN 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT607425S, CWT607374S, CWT607359S, CWT601622S, CWT603529S, CWT605876S, CWT605723S, CWT604657S, CWT604666S, CWT605105S, CWT605034S, CWT608381S, CWT608194S, CWT606083S, CWT604306S, CWT606483S, CWT607258S, CWT606731S, CWT605978S, CWT607015S, CWT606443S, CWT607932S, CWT608011S, CWT607139S, CWT606486S, CWT605678S, CWT607017S, CWT607943S, CWT608012S, CWT606735S, CWT606736S, CWT606738S, CWT606739S, CWT606741S, CWT606742S, CWT606743S, CWT606744S, CWT606745S, CWT606746S, CWT606747S, CWT606748S, CWT606749S, CWT606750S, CWT603376S, CWT607308S, CWT602883S, CWT603530S, CWT604069S, CWT604509S, CWT604647S, CWT604878S, CWT605689S, CWT605944S, CWT606036S, CWT600803S, CWT601014S, CWT601028S, CWT601179S, CWT601231S, CWT601422S, CWT602980S, CWT602981S, CWT603019S, CWT603216S, CWT603319S, CWT603320S, CWT604576S, CWT605154S, CWT600275S, CWT601002S, CWT601180S, CWT601388S, CWT601407S, CWT601417S, CWT601516S, CWT601527S, CWT601652S, CWT601681S, CWT601719S, CWT601946S, CWT602082S, CWT602826S, CWT602908S, CWT602909S, CWT603061S, CWT603503S, CWT603506S, CWT603642S, CWT604058S, CWT604226S, CWT604247S, CWT604526S, CWT604690S, CWT604887S… Full codes in the FDA record | 8219 units |
| Z-1721-2023 | ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators; GTIN 00763000178338, Lot Serial Numbers: RSL602442S, RSL601336S, RSL600186S, RSL602060S, RSL601499S, RSL601501S, RSL602893S, RSL602901S, RSL602941S, RSL602955S, RSL602420S, RSL602899S, RSL601490S, RSL602690S, RSL600167S, RSL600499S, RSL600561S, RSL600563S, RSL600564S, RSL600565S, RSL601867S, RSL601868S, RSL601870S, RSL601966S, RSL603729S, RSL601838S, RSL602889S, RSL600163S, RSL602444S, RSL602823S, RSL602826S, RSL603092S, RSL603105S, RSL603233S, RSL603237S, RSL603565S, RSL600206S, RSL600230S, RSL600231S, RSL601723S, RSL601789S, RSL601878S, RSL602705S, RSL602854S, RSL602828S, RSL602933S, RSL603236S, RSL601484S, RSL601988S, RSL603618S, RSL602324S, RSL602979S, RSL603759S, RSL600237S, RSL601990S, RSL600172S, RSL602465S, RSL602466S, RSL602467S, RSL602468S, RSL602469S, RSL602470S, RSL602471S, RSL602472S, RSL602892S, RSL603257S, RSL603262S, RSL603263S, RSL603264S, RSL601873S, RSL601874S, RSL601875S, RSL601876S, RSL601887S, RSL601895S, RSL602043S, RSL602044S, RSL602045S, RSL602046S, RSL602047S, RSL602048S, RSL602049S, RSL602050S, RSL602051S, RSL602052S, RSL602053S, RSL602054S, RSL602055S, RSL602056S, RSL602058S, RSL602059S, RSL602221S, RSL602222S, RSL602223S, RSL602224S, RSL602225S, RSL602227S, RSL602228S, RSL602229S… Full codes in the FDA record | 2748 units |
| Z-1722-2023 | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators; GTIN 00763000615611. Lot Serial Numbers: RSL602260S, RSL602263S, RSL602265S | 3 units |
| Z-1723-2023 | ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators; GTIN 00763000178345, Lot Serial Numbers: RSM612933S, RSM612934S, RSM612935S, RSM621211S, RSM604622S, RSM604623S, RSM608882S, RSM621210S, RSM621212S, RSM612673S, RSM609800S, RSM610899S, RSM619550S, RSM620275S, RSM620130S, RSM615997S, RSM619083S, RSM623383S, RSM623721S, RSM610958S, RSM616552S, RSM614351S, RSM618224S, RSM604877S, RSM612655S, RSM612656S, RSM612657S, RSM612659S, RSM621000S, RSM621003S, RSM621005S, RSM608749S, RSM608750S, RSM608751S, RSM608752S, RSM610434S, RSM610435S, RSM620999S, RSM621001S, RSM621004S, RSM617554S, RSM617555S, RSM617556S, RSM617558S, RSM617559S, RSM617557S, RSM613882S, RSM614841S, RSM615782S, RSM615936S, RSM616172S, RSM616444S, RSM619209S, RSM619289S, RSM619651S, RSM619896S, RSM620690S, RSM600889S, RSM604260S, RSM605557S, RSM606370S, RSM606396S, RSM607298S, RSM610073S, RSM610769S, RSM612584S, RSM618160S, RSM623166S, RSM600390S, RSM600757S, RSM600770S, RSM600846S, RSM600890S, RSM601127S, RSM601129S, RSM601133S, RSM604873S, RSM605085S, RSM605586S, RSM605863S, RSM605974S, RSM606168S, RSM606211S, RSM606217S, RSM606273S, RSM606468S, RSM607358S, RSM607466S, RSM608015S, RSM608017S, RSM608063S, RSM609483S, RSM609943S, RSM610757S, RSM611542S, RSM612678S, RSM614146S, RSM614433S, RSM619501S… Full codes in the FDA record | 22,114 units |
| Z-1724-2023 | ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators; GTIN 00763000615628, Lot Serial Numbers: RSM616778S, RSM610606S, RSM611337S, RSM610608S, RSM611339S; GTIN 00763000645502, Lot Serial Numbers: RSM616777S | 6 units |
| Z-1725-2023 | ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators; GTIN 00763000178376, Lot Serial Numbers: RSN600341S, RSN601060S, RSN601316S, RSN601817S, RSN602193S, RSN600668S, RSN600669S, RSN600670S, RSN600672S, RSN601804S, RSN601808S, RSN601810S, RSN602514S, RSN601050S, RSN601241S, RSN602551S, RSN600820S, RSN603061S, RSN601870S, RSN602495S, RSN601384S, RSN601691S, RSN601237S, RSN602951S, RSN603065S, RSN600626S, RSN600877S, RSN601019S, RSN601020S, RSN601022S, RSN601027S, RSN601028S, RSN601029S, RSN601030S, RSN601032S, RSN601038S, RSN601040S, RSN600997S, RSN601013S, RSN601039S, RSN600837S, RSN601913S, RSN601957S, RSN600334S, RSN600116S, RSN602781S, RSN602004S, RSN602073S, RSN601983S, RSN600628S, RSN601374S, RSN600624S, RSN601004S, RSN601902S, RSN602210S, RSN600402S, RSN600359S, RSN600360S, RSN600361S, RSN600366S, RSN601283S, RSN602071S, RSN602182S, RSN602365S, RSN602756S, RSN602171S, RSN600482S, RSN600870S, RSN601950S, RSN602490S, RSN600952S, RSN602026S, RSN602072S, RSN602244S, RSN602297S, RSN600640S, RSN601351S, RSN601352S, RSN601830S, RSN601831S, RSN600813S, RSN600891S, RSN601202S, RSN601390S, RSN602166S, RSN602167S, RSN602245S, RSN600550S, RSN601897S, RSN602283S, RSN602325S, RSN602485S, RSN600459S, RSN600461S, RSN600463S, RSN600574S, RSN600639S, RSN600918S, RSN601080S, RSN601116S… Full codes in the FDA record | 1941 units |
| Z-1726-2023 | ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators; GTIN 00763000178390, Lot Serial Numbers: RSO600207S, RSO600934S, RSO602587S, RSO602860S, RSO603892S, RSO600679S, RSO612257S, RSO602636S, RSO604992S, RSO609567S, RSO609647S, RSO609795S, RSO609900S, RSO610931S, RSO607136S, RSO609278S, RSO601095S, RSO601096S, RSO601098S, RSO601472S, RSO601473S, RSO601474S, RSO601475S, RSO601476S, RSO601477S, RSO601478S, RSO601479S, RSO604357S, RSO604358S, RSO605928S, RSO606135S, RSO606155S, RSO603632S, RSO603681S, RSO607412S, RSO607605S, RSO610650S, RSO600968S, RSO601258S, RSO603258S, RSO603300S, RSO603339S, RSO603742S, RSO603773S, RSO612385S, RSO601910S, RSO601911S, RSO601913S, RSO602604S, RSO602611S, RSO603824S, RSO603826S, RSO603876S, RSO609857S, RSO610204S, RSO609865S, RSO610317S, RSO601050S, RSO601392S, RSO601568S, RSO601741S, RSO604464S, RSO600230S, RSO610679S, RSO612158S, RSO612159S, RSO608401S, RSO608413S, RSO613154S, RSO613155S, RSO609928S, RSO610881S, RSO611808S, RSO600081S, RSO600082S, RSO600083S, RSO600951S, RSO600986S, RSO601604S, RSO604972S, RSO605522S, RSO606607S, RSO607741S, RSO606041S, RSO601440S, RSO605663S, RSO607178S, RSO607206S, RSO609698S, RSO603723S, RSO602519S, RSO603022S, RSO603027S, RSO603552S, RSO603805S, RSO603832S, RSO603833S, RSO604179S, RSO604194S, RSO604476S… Full codes in the FDA record | 11,645 units |
| Z-1727-2023 | ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators; GTIN 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S, RSP600059S, RSP600219S, RSP600079S, RSP600190S, RSP600398S, RSP600217S, RSP600230S, RSP600723S, RSP600203S, RSP600221S, RSP600187S, RSP600250S, RSP600276S, RSP600060S, RSP600267S, RSP600392S, RSP600813S, RSP600154S, RSP600209S, RSP600211S… Full codes in the FDA record | 487 units |
| Z-1728-2023 | ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators; GTIN 00763000178437, Lot Serial Numbers: RSQ600736S, RSQ600745S, RSQ600905S, RSQ600975S, RSQ601406S, RSQ600113S, RSQ600114S, RSQ600115S, RSQ600255S, RSQ600256S, RSQ600257S, RSQ600258S, RSQ600261S, RSQ600740S, RSQ601122S, RSQ601137S, RSQ601177S, RSQ601178S, RSQ601179S, RSQ601181S, RSQ601227S, RSQ601228S, RSQ601229S, RSQ601375S, RSQ601377S, RSQ600055S, RSQ600163S, RSQ600164S, RSQ600936S, RSQ601151S, RSQ600049S, RSQ600051S, RSQ600713S, RSQ600991S, RSQ601411S, RSQ601416S, RSQ600218S, RSQ600237S, RSQ600679S, RSQ600712S, RSQ600723S, RSQ600772S, RSQ600074S, RSQ600090S, RSQ600012S, RSQ600053S, RSQ600811S, RSQ600843S, RSQ600912S, RSQ600913S, RSQ600195S, RSQ600894S, RSQ600981S, RSQ600748S, RSQ601201S, RSQ601378S, RSQ601479S, RSQ601490S, RSQ600782S, RSQ600665S, RSQ600091S, RSQ600105S, RSQ600106S, RSQ600130S, RSQ600174S, RSQ600183S, RSQ600185S, RSQ600216S, RSQ600767S, RSQ600788S, RSQ600799S, RSQ601445S, RSQ601447S, RSQ601448S, RSQ601451S, RSQ601452S, RSQ600704S, RSQ600743S, RSQ600773S, RSQ600808S, RSQ600262S, RSQ602018S, RSQ600101S, RSQ600738S, RSQ600093S, RSQ600125S, RSQ600128S, RSQ600140S, RSQ600678S, RSQ600694S, RSQ600737S, RSQ600744S, RSQ600750S, RSQ600753S, RSQ600754S, RSQ600780S, RSQ600789S, RSQ600807S, RSQ600829S, RSQ600906S… Full codes in the FDA record | 2018 Units |
| Z-1729-2023 | CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators; GTIN 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF257081H, BLF257089H, BLF257260H, BLF257290H, BLF257410H, BLF257440H, BLF257565H, BLF257668H, BLF257684H, BLF257873H, BLF257966H, BLF256897H, BLF257648H, BLF256756H, BLF256776H, BLF256865H, BLF257835H, BLF257086H, BLF257198H, BLF257413H, BLF257605H, BLF257611H, BLF257863H, BLF257960H, BLF257342H, BLF257460H, BLF257657H, BLF256948H, BLF257877H, BLF256848H, BLF257404H, BLF257931H, BLF257961H, BLF258043H, BLF258080H, BLF257904H, BLF257104H, BLF257029H, BLF257408H, BLF257431H, BLF257388H, BLF257618H, BLF257916H, BLF257972H, BLF256843H, BLF256844H, BLF256971H, BLF257125H, BLF257347H, BLF258090H, BLF257677H, BLF258051H, BLF257844H, BLF257627H, BLF257348H, BLF258261H, BLF257215H, BLF257468H, BLF256758H, BLF257803H, BLF258143H, BLF257449H, BLF257885H, BLF257899H, BLF257956H, BLF258078H, BLF258093H, BLF258094H, BLF258178H, BLF258228H, BLF257037H, BLF257384H, BLF258292H, BLF257430H, BLF257459H, BLF256911H, BLF256979H, BLF256984H, BLF256999H, BLF257398H, BLF257568H, BLF257682H, BLF258129H, BLF258141H, BLF258202H, BLF258219H, BLF258236H, BLF258294H, BLF256867H, BLF257276H, BLF258268H, BLF256968H, BLF256969H… Full codes in the FDA record | 1473 units |
| Z-1730-2023 | CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators; GTIN 00643169956650, Lot Serial Numbers: BLF258300H | 1 unit |
| Z-1731-2023 | CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720251, Lot Serial Numbers: BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE221190H, BLE221267H, BLE221842H, BLE221265H, BLE221430H, BLE221711H, BLE221346H, BLE221631H, BLE221285H, BLE221405H, BLE221436H, BLE221551H, BLE221411H, BLE221342H, BLE221584H, BLE221694H, BLE221282H, BLE221465H, BLE221191H, BLE221384H, BLE221805H, BLE221309H, BLE221222H, BLE221327H, BLE221548H, BLE221562H, BLE221702H, BLE221450H, BLE221715H, BLE221246H, BLE221654H, BLE221686H, BLE221713H, BLE221750H, BLE221758H, BLE221814H, BLE221828H, BLE221843H, BLE221844H, BLE221851H, BLE221854H, BLE221855H, BLE221861H, BLE221561H, BLE221727H, BLE221751H, BLE221789H, BLE221862H, BLE221670H, BLE221707H, BLE221752H, BLE221849H, BLE221475H, BLE221687H, BLE221601H, BLE221748H, BLE221173H, BLE221336H, BLE221413H, BLE221426H, BLE221580H, BLE221174H, BLE221176H, BLE221759H, BLE221227H, BLE221660H, BLE221334H, BLE221627H, BLE220376H, BLE221338H, BLE221213H, BLE221349H, BLE221658H, BLE221661H, BLE221348H, BLE221378H, BLE221423H, BLE221680H, BLE221808H, BLE221542H, BLE221633H, BLE221819H, BLE221863H, BLE221292H, BLE221368H, BLE221492H, BLE221608H, BLE221269H, BLE221700H, BLE221418H, BLE221251H, BLE221761H, BLE221242H… Full codes in the FDA record | 661 units |
| Z-1732-2023 | CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators; GTIN 00643169720190, Lot Serial Numbers: BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H, BLD212702H, BLD212556H, BLD211866H, BLD212723H, BLD211867H, BLD212688H, BLD212565H, BLD212615H, BLD212627H, BLD212732H, BLD212785H, BLD212912H, BLD212919H, BLD212951H, BLD212993H, BLD213011H, BLD213015H, BLD213032H, BLD213042H… Full codes in the FDA record | 373 units |
| Z-1733-2023 | CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, BLC228296H, BLC228583H, BLC228787H, BLC228926H, BLC229106H, BLC228579H, BLC228245H, BLC228551H, BLC228625H, BLC228819H, BLC228440H, BLC228622H, BLC228825H, BLC228456H, BLC228432H, BLC228960H, BLC229166H, BLC228545H, BLC228676H, BLC228695H, BLC228573H, BLC229089H, BLC228721H, BLC228898H, BLC228980H, BLC229099H, BLC228302H, BLC228256H, BLC228258H, BLC228300H, BLC228319H, BLC228355H, BLC228394H, BLC228406H, BLC228450H, BLC228461H, BLC228515H, BLC228309H, BLC228379H, BLC228491H, BLC228510H, BLC228511H, BLC228577H, BLC228707H, BLC228800H, BLC228861H, BLC229110H, BLC229192H, BLC229207H, BLC229107H, BLC228228H, BLC228312H, BLC229032H, BLC229062H, BLC229094H, BLC229161H, BLC229169H, BLC229210H, BLC228653H, BLC228685H, BLC228409H, BLC229144H, BLC228581H, BLC228940H, BLC229154H, BLC228580H, BLC228509H, BLC228593H, BLC228614H, BLC229219H, BLC228386H… Full codes in the FDA record | 891 units |
| Z-1734-2023 | CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators; GTIN 00643169968585, Lot Serial Numbers: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, BLC229010H | 14 units |
| Z-1735-2023 | CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators; GTIN 00643169217959; Lot Serial Numbers: BLJ622286S, BLJ622571S, BLJ622623S, BLJ622733S, BLJ622742S, BLJ622966S, BLJ624144S, BLJ622126S, BLJ624009S, BLJ622569S, BLJ623322S, BLJ622064S, BLJ622092S, BLJ623468S, BLJ623621S, BLJ623849S, BLJ624135S, BLJ622023S, BLJ623580S, BLJ624033S, BLJ623167S, BLJ623490S, BLJ622292S, BLJ622241S, BLJ623462S, BLJ623794S, BLJ623809S, BLJ624193S, BLJ621886S, BLJ621947S, BLJ622884S, BLJ623297S, BLJ623410S, BLJ623471S, BLJ624039S, BLJ621718S, BLJ622266S, BLJ622481S, BLJ622566S, BLJ622575S, BLJ622578S, BLJ622582S, BLJ622596S, BLJ622621S, BLJ622732S, BLJ622903S, BLJ622934S, BLJ622973S, BLJ623089S, BLJ623300S, BLJ623319S, BLJ623411S, BLJ623413S, BLJ623482S, BLJ623605S, BLJ623615S, BLJ623620S, BLJ623631S, BLJ623771S, BLJ623960S, BLJ622066S, BLJ622581S, BLJ623080S, BLJ623147S, BLJ621736S, BLJ621763S, BLJ622067S, BLJ622237S, BLJ622458S, BLJ622007S, BLJ622992S, BLJ623036S, BLJ623110S, BLJ623296S, BLJ623460S, BLJ623578S, BLJ624142S, BLJ622127S, BLJ622277S, BLJ623416S, BLJ623898S, BLJ623929S, BLJ621944S, BLJ622739S, BLJ622740S, BLJ622068S, BLJ622613S, BLJ623776S, BLJ623883S, BLJ624067S, BLJ624201S, BLJ623454S, BLJ624132S, BLJ622061S, BLJ622015S, BLJ622288S, BLJ622729S, BLJ624010S, BLJ622948S… Full codes in the FDA record | 4354 units |
| Z-1736-2023 | CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators; GTIN 00763000071431, Lot Serial Numbers: BLJ622587S, BLJ622075S, BLJ622585S, BLJ623836S, BLJ622076S, BLJ623838S, BLJ622586S, BLJ623837S | 8 units |
| Z-1737-2023 | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators; GTIN 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S, BLI613418S, BLI613649S, BLI613879S, BLI614325S, BLI612962S, BLI613272S, BLI614595S, BLI613243S, BLI613284S, BLI614472S, BLI612753S, BLI613334S, BLI613664S, BLI612828S, BLI614463S, BLI614487S, BLI614772S, BLI614781S, BLI612721S… Full codes in the FDA record | 2904 units |
| Z-1738-2023 | CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators; GTIN 00643169400603, Lot Serial Numbers: BLH605909S, BLH605759S, BLH605781S, BLH605675S, BLH605010S, BLH605692S, BLH605674S, BLH605156S, BLH605237S, BLH605376S, BLH605837S, BLH605887S, BLH605736S, BLH605691S, BLH605953S, BLH604859S, BLH605700S, BLH605904S, BLH605933S, BLH605945S, BLH605854S, BLH605929S, BLH605742S, BLH605709S, BLH605877S, BLH605786S, BLH605711S, BLH605574S, BLH605747S, BLH605932S, BLH604888S, BLH605014S, BLH605399S, BLH605699S, BLH605705S, BLH605729S, BLH605732S, BLH605806S, BLH605239S, BLH605233S, BLH605704S, BLH605730S, BLH605821S, BLH605400S, BLH605011S, BLH605850S, BLH605707S, BLH605241S, BLH605819S, BLH605820S, BLH605577S, BLH605235S, BLH604907S, BLH605676S, BLH605915S, BLH605319S, BLH605582S, BLH605391S, BLH605519S, BLH605589S, BLH605741S, BLH604904S, BLH605738S, BLH605835S, BLH605845S, BLH605846S, BLH605823S, BLH604886S, BLH605151S, BLH605398S, BLH605702S, BLH605591S, BLH605394S, BLH605672S, BLH605726S, BLH605581S, BLH605790S, BLH605397S, BLH605791S, BLH605690S, BLH605708S, BLH604902S, BLH605157S, BLH605733S, BLH605861S, BLH605584S, BLH605746S, BLH605145S, BLH604878S, BLH605719S, BLH605232S, BLH605269S, BLH605826S, BLH605737S, BLH605871S, BLH605373S, BLH605739S, BLH605388S… Full codes in the FDA record | 1132 units |
| Z-1739-2023 | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720169, Lot Serial Numbers: BLG624311S, BLG624755S, BLG625177S, BLG625181S, BLG625182S, BLG625188S, BLG625193S, BLG625324S, BLG625325S, BLG625434S, BLG625596S, BLG625598S, BLG625606S, BLG625608S, BLG625636S, BLG625647S, BLG625702S, BLG625740S, BLG625741S, BLG625745S, BLG625962S, BLG626105S, BLG626141S, BLG624936S, BLG624987S, BLG624995S, BLG625164S, BLG625167S, BLG625168S, BLG625242S, BLG625247S, BLG625565S, BLG625566S, BLG625568S, BLG625573S, BLG625616S, BLG625619S, BLG625620S, BLG625624S, BLG625651S, BLG625653S, BLG625655S, BLG625656S, BLG625489S, BLG625612S, BLG625910S, BLG624312S, BLG625331S, BLG624790S, BLG624843S, BLG624880S, BLG624881S, BLG624878S, BLG625644S, BLG624773S, BLG625148S, BLG625224S, BLG624958S, BLG625000S, BLG624751S, BLG624884S, BLG624890S, BLG624895S, BLG624896S, BLG624901S, BLG625171S, BLG625173S, BLG625175S, BLG625197S, BLG625571S, BLG625597S, BLG625605S, BLG625626S, BLG625630S, BLG625705S, BLG625876S, BLG626149S, BLG625650S, BLG625631S, BLG625228S, BLG625243S, BLG624759S, BLG625953S, BLG624816S, BLG624819S, BLG624827S, BLG624863S, BLG624889S, BLG624792S, BLG624795S, BLG625013S, BLG625023S, BLG625025S, BLG625304S, BLG625308S, BLG625311S, BLG625312S, BLG625317S… Full codes in the FDA record | 2931 units |
| Z-1740-2023 | CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators; GTIN 00643169518223, Lot Serial Numbers: BLG626306S | 1 unit |
| Z-1741-2023 | CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169720329, Lot Serial Numbers: BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H… Full codes in the FDA record | 207 units |
| Z-1742-2023 | CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720268, Lot Serial Numbers: BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN205573H, BLN205101H, BLN205395H, BLN205424H, BLN205448H, BLN205505H, BLN205574H, BLN205579H, BLN205432H, BLN205460H, BLN205545H, BLN205566H, BLN205554H, BLN205583H, BLN205390H, BLN205669H, BLN205438H, BLN205653H, BLN205533H, BLN205387H, BLN205527H, BLN205528H, BLN205571H, BLN205591H, BLN205623H, BLN205485H, BLN205501H, BLN205594H, BLN205618H, BLN205381H, BLN205462H, BLN205684H, BLN205479H, BLN205509H, BLN205627H, BLN205663H, BLN205682H, BLN205382H, BLN205384H, BLN205549H, BLN205557H, BLN205482H, BLN205454H, BLN205548H, BLN205560H, BLN205408H, BLN205521H, BLN205529H, BLN205552H, BLN205491H, BLN205645H, BLN205586H, BLN205480H, BLN205516H, BLN205486H, BLN205520H, BLN205417H, BLN205415H, BLN205558H, BLN205630H, BLN205655H, BLN205458H, BLN205435H, BLN205428H, BLN205555H, BLN205446H, BLN205420H, BLN205481H, BLN205399H, BLN205437H, BLN205459H, BLN205463H, BLN205476H, BLN205477H, BLN205518H, BLN205565H, BLN205575H, BLN205577H, BLN205611H, BLN205624H, BLN205457H, BLN205506H, BLN205643H, BLN205648H, BLN205652H, BLN205434H, BLN205456H, BLN205441H, BLN205507H, BLN205592H, BLN205650H, BLN205596H, BLN205570H… Full codes in the FDA record | 182 units |
| Z-1743-2023 | CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators; GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM203031H, BLM203063H, BLM202844H, BLM202900H, BLM203042H, BLM203014H, BLM203015H, BLM203062H, BLM202811H, BLM202838H, BLM202857H, BLM202858H, BLM202881H, BLM202923H, BLM203001H, BLM203021H, BLM202848H, BLM202878H, BLM202827H, BLM202952H, BLM203061H, BLM202909H, BLM202921H, BLM202942H, BLM202830H, BLM202850H, BLM202886H, BLM202888H, BLM202829H, BLM202911H, BLM202958H, BLM202982H, BLM203037H, BLM202945H, BLM202929H, BLM202949H, BLM202973H, BLM202828H, BLM202990H, BLM202947H, BLM202960H, BLM202854H, BLM202944H, BLM202810H, BLM202847H, BLM202862H, BLM202880H, BLM202904H, BLM202946H, BLM202974H, BLM202979H, BLM203006H, BLM203012H, BLM203040H, BLM202932H, BLM202913H, BLM202940H, BLM202842H, BLM202980H, BLM203029H, BLM203058H, BLM203065H, BLM202972H, BLM203051H, BLM202867H, BLM202948H, BLM203004H, BLM202832H, BLM202999H, BLM202885H, BLM202976H, BLM203035H, BLM203009H, BLM203024H, BLM202914H, BLM203002H, BLM202833H, BLM202983H, BLM202985H, BLM202986H, BLM202987H, BLM202988H, BLM202992H, BLM202996H, BLM203003H, BLM203005H, BLM203008H, BLM203016H, BLM203022H, BLM203043H, BLM203046H, BLM203047H, BLM203048H… Full codes in the FDA record | — |
| Z-1744-2023 | CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720145, Lot Serial Numbers: BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H, BLK205372H, BLK205458H, BLK205494H, BLK205498H, BLK205570H, BLK205341H, BLK205305H, BLK205317H, BLK205354H, BLK205468H, BLK205469H, BLK205574H, BLK205345H, BLK205363H, BLK205378H, BLK205539H, BLK205534H, BLK205535H, BLK205536H… Full codes in the FDA record | 193 units |
| Z-1745-2023 | CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS604309S, BLS604224S, BLS604227S, BLS604222S, BLS604308S, BLS604256S, BLS604257S, BLS604310S, BLS604313S, BLS604245S, BLS604253S, BLS604252S, BLS604239S, BLS604226S, BLS604371S, BLS604380S, BLS604417S, BLS604419S, BLS604432S, BLS604560S, BLS604562S, BLS604366S, BLS604368S, BLS604375S, BLS604376S, BLS604169S, BLS604170S, BLS604360S, BLS604365S, BLS604369S, BLS604372S, BLS604379S, BLS604525S, BLS604554S, BLS604572S, BLS604363S, BLS604171S, BLS604361S, BLS604377S, BLS604378S, BLS604418S, BLS604428S, BLS604434S, BLS604556S, BLS604561S, BLS604567S, BLS604571S, BLS604563S, BLS604362S, BLS604364S, BLS604370S, BLS604373S, BLS604422S, BLS604523S, BLS604524S, BLS604543S, BLS604548S, BLS604564S, BLS604570S, BLS604279S, BLS604280S, BLS604281S, BLS604316S, BLS604320S, BLS604321S, BLS604322S, BLS604323S, BLS604324S, BLS604326S, BLS604328S, BLS604317S, BLS604318S, BLS604319S, BLS604416S, BLS604421S, BLS604243S, BLS604305S, BLS604399S, BLS604503S, BLS604549S, BLS604367S, BLS604345S, BLS604501S, BLS604410S, BLS604502S, BLS604528S, BLS604325S, BLS604384S, BLS604391S, BLS604392S, BLS604400S, BLS604487S, BLS604496S… Full codes in the FDA record | 1076 units |
| Z-1746-2023 | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720299, Lot Serial Numbers; BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S; GTIN 00643169980112, Lot Serial Numbers: BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, BLR602537S, BLR602540S, BLR602542S, BLR602544S, BLR602545S, BLR602546S, BLR602548S, BLR602550S, BLR602552S, BLR602554S, BLR602555S, BLR602587S, BLR602632S, BLR602633S, BLR602638S, BLR602639S, BLR602640S, BLR602644S, BLR602645S, BLR602647S, BLR602669S… Full codes in the FDA record | 435 units |
| Z-1747-2023 | CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators; GTIN 00643169980181, Lot Serial Numbers: BLQ600039S, BLQ600033S, BLQ600034S, BLQ600035S, BLQ600036S, BLQ600037S, BLQ600038S | 7 units |
| Z-1748-2023 | CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720176, Lot Serial Numbers: BLP603514S, BLP603579S, BLP603583S, BLP603637S, BLP603643S, BLP603554S, BLP603588S, BLP603580S, BLP603582S, BLP603584S, BLP603585S, BLP603586S, BLP603591S, BLP603531S, BLP603552S, BLP603511S, BLP603647S, BLP603581S, BLP603545S, BLP603551S, BLP603569S, BLP603648S, BLP603808S, BLP603536S, BLP603538S, BLP603542S, BLP603543S, BLP603544S, BLP603546S, BLP603549S, BLP603550S, BLP603553S, BLP603555S, BLP603557S, BLP603558S, BLP603562S, BLP603563S, BLP603576S, BLP603577S, BLP603587S, BLP603641S, BLP603670S, BLP603671S, BLP603672S, BLP603673S, BLP603674S, BLP603675S, BLP603676S, BLP603677S, BLP603678S, BLP603729S, BLP603730S, BLP603732S, BLP603733S, BLP603734S, BLP603735S, BLP603736S, BLP603409S, BLP603529S, BLP603533S, BLP603666S, BLP603689S, BLP603716S, BLP603758S, BLP603762S, BLP603786S, BLP603794S, BLP603795S, BLP603798S, BLP603801S, BLP603804S, BLP603807S, BLP603626S, BLP603627S, BLP603628S, BLP603629S, BLP603630S, BLP603631S, BLP603632S, BLP603633S, BLP603703S, BLP603704S, BLP603705S, BLP603706S, BLP603707S, BLP603709S, BLP603710S, BLP603711S, BLP603742S, BLP603747S, BLP603748S, BLP603779S, BLP603780S, BLP603781S, BLP603782S, BLP603783S, BLP603410S, BLP603512S… Full codes in the FDA record | 523 units |
| Z-1749-2023 | CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators; GTIN 00643169720367, Lot Serial Numbers: BLW607464S, BLW607601S, BLW607643S, BLW607705S, BLW607921S, BLW608132S, BLW608133S, BLW608134S, BLW608135S, BLW608235S, BLW608746S, BLW609769S, BLW606989S, BLW607809S, BLW607902S, BLW607917S, BLW607284S, BLW607004S, BLW607851S, BLW607173S, BLW607320S, BLW607015S, BLW607319S, BLW607257S, BLW607269S, BLW607346S, BLW607361S, BLW607031S, BLW607243S, BLW606959S, BLW607058S, BLW607285S, BLW607580S, BLW607394S, BLW607249S, BLW607505S, BLW607573S, BLW606999S, BLW607254S, BLW607835S, BLW607159S, BLW606948S, BLW606961S, BLW607044S, BLW607113S, BLW607292S, BLW607406S, BLW607498S, BLW607661S, BLW607758S, BLW607759S, BLW607865S, BLW607248S, BLW607866S, BLW607021S, BLW607598S, BLW607665S, BLW607823S, BLW607493S, BLW607001S, BLW607817S, BLW607841S, BLW607883S, BLW607747S, BLW608268S, BLW607287S, BLW607356S, BLW607440S, BLW607473S, BLW607636S, BLW607709S, BLW607943S, BLW606941S, BLW607330S, BLW607029S, BLW607205S, BLW607207S, BLW607818S, BLW607896S, BLW607847S, BLW606952S, BLW607639S, BLW607640S, BLW607209S, BLW607230S, BLW607859S, BLW607300S, BLW606991S, BLW607037S, BLW607252S, BLW607468S, BLW607477S, BLW607513S, BLW607863S, BLW607927S, BLW607946S, BLW607188S, BLW607268S, BLW607360S… Full codes in the FDA record | 7921 units |
| Z-1750-2023 | CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ604013S, BLZ604101S, BLZ603725S, BLZ604036S, BLZ604059S, BLZ603770S, BLZ604032S, BLZ603602S, BLZ603626S, BLZ604001S, BLZ603743S, BLZ604536S, BLZ603622S, BLZ604076S, BLZ604915S, BLZ604263S, BLZ603735S, BLZ603422S, BLZ603918S, BLZ604138S, BLZ603587S, BLZ603604S, BLZ603663S, BLZ603723S, BLZ603840S, BLZ604082S, BLZ604065S, BLZ604080S, BLZ604102S, BLZ603740S, BLZ603967S, BLZ604467S, BLZ603620S, BLZ603705S, BLZ603788S, BLZ603812S, BLZ603977S, BLZ603978S, BLZ603980S, BLZ604031S, BLZ604072S, BLZ604134S, BLZ604097S, BLZ603639S, BLZ603941S, BLZ604056S, BLZ603594S, BLZ603683S, BLZ603720S, BLZ603898S, BLZ603921S, BLZ603982S, BLZ603983S, BLZ604057S, BLZ604135S, BLZ604908S, BLZ603732S, BLZ603787S, BLZ604146S, BLZ603643S, BLZ603958S, BLZ604107S, BLZ603796S, BLZ603605S, BLZ603902S, BLZ604049S, BLZ603694S, BLZ604103S, BLZ603716S, BLZ604111S, BLZ604006S, BLZ604110S, BLZ604099S, BLZ603874S, BLZ603894S, BLZ604093S, BLZ603972S, BLZ603859S, BLZ603603S, BLZ603614S, BLZ603856S, BLZ604005S, BLZ603595S, BLZ603813S, BLZ603880S, BLZ603899S, BLZ604014S, BLZ604053S, BLZ604016S, BLZ604017S, BLZ603879S, BLZ604051S, BLZ603615S… Full codes in the FDA record | 3355 units |
| Z-1751-2023 | CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators; GTIN 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY602563S, BLY602693S, BLY602474S, BLY602424S, BLY602465S, BLY602812S, BLY602676S, BLY602445S, BLY602572S, BLY602497S, BLY602549S, BLY602715S, BLY602735S, BLY602531S, BLY602657S, BLY603005S, BLY602489S, BLY602628S, BLY602652S, BLY602459S, BLY602483S, BLY602576S, BLY602450S, BLY602521S, BLY602574S, BLY602680S, BLY602386S, BLY602463S, BLY602694S, BLY602747S, BLY602449S, BLY602401S, BLY602413S, BLY602432S, BLY602631S, BLY602633S, BLY602672S, BLY602740S, BLY602741S, BLY602403S, BLY602412S, BLY602517S, BLY602528S, BLY602430S, BLY602501S, BLY602270S, BLY602552S, BLY602713S, BLY602478S, BLY602543S, BLY602443S, BLY602464S, BLY602634S, BLY602421S, BLY602564S, BLY602462S, BLY602525S, BLY602673S, BLY602717S, BLY602734S, BLY602467S, BLY602487S, BLY602377S, BLY602682S, BLY602712S, BLY602423S, BLY602659S, BLY602725S, BLY602393S, BLY602524S, BLY602565S, BLY602630S, BLY602378S, BLY602696S, BLY602438S, BLY602475S, BLY602653S, BLY602711S, BLY602661S, BLY602539S, BLY602533S, BLY602558S, BLY602561S, BLY602675S, BLY602534S, BLY602499S, BLY602814S, BLY602368S, BLY602437S, BLY602727S, BLY602435S, BLY602444S, BLY602530S… Full codes in the FDA record | 1754 units |
| Z-1752-2023 | CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX611227S, BLX610459S, BLX613336S, BLX611231S, BLX610972S, BLX610821S, BLX611566S, BLX611238S, BLX610596S, BLX610449S, BLX610925S, BLX611306S, BLX610523S, BLX611147S, BLX611439S, BLX610568S, BLX611464S, BLX611546S, BLX611733S, BLX611813S, BLX612082S, BLX612083S, BLX612440S, BLX611069S, BLX611190S, BLX611293S, BLX610441S, BLX611452S, BLX610586S, BLX610739S, BLX611422S, BLX610467S, BLX610671S, BLX611002S, BLX611400S, BLX611499S, BLX611540S, BLX611542S, BLX611554S, BLX611561S, BLX611732S, BLX610299S, BLX611218S, BLX611398S, BLX611547S, BLX611549S, BLX611565S, BLX611613S, BLX610991S, BLX611110S, BLX611987S, BLX610490S, BLX611737S, BLX610446S, BLX610447S, BLX611511S, BLX611605S, BLX610480S, BLX611940S, BLX611927S, BLX610329S, BLX610451S, BLX610464S, BLX610989S, BLX611220S, BLX611515S, BLX611564S, BLX611611S, BLX611742S, BLX611923S, BLX610854S, BLX611391S, BLX611392S, BLX611931S, BLX611943S, BLX610340S, BLX611357S, BLX610393S, BLX610614S, BLX610931S, BLX610937S, BLX610978S, BLX611312S, BLX611366S, BLX611739S, BLX611962S, BLX611982S, BLX610624S, BLX611988S, BLX610470S, BLX611616S, BLX611201S, BLX611688S… Full codes in the FDA record | 7994 units |
| Z-1753-2023 | CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators; GTIN 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H, RPT211406H, RPT204980H, RPT205294H, RPT208424H, RPT208705H, RPT209144H, RPT209238H, RPT209858H, RPT210083H, RPT210593H, RPT210747H, RPT210979H, RPT211230H, RPT211701H, RPT209577H, RPT209848H, RPT211158H, RPT205289H, RPT206148H… Full codes in the FDA record | 11794 units |
| Z-1754-2023 | CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H, RPC204556H, RPC207683H, RPC208161H, RPC208598H, RPC208896H, RPC209484H, RPC203280H, RPC203999H, RPC204866H, RPC204869H, RPC204871H, RPC204874H, RPC205657H, RPC205859H, RPC205860H, RPC206559H, RPC206713H, RPC207077H, RPC207577H… Full codes in the FDA record | 12291 units |
| Z-1755-2023 | CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators; GTIN 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H, RPS206515H, RPS202224H, RPS203192H, RPS203545H, RPS203910H, RPS204035H, RPS204166H, RPS204197H, RPS204394H, RPS204492H, RPS205560H, RPS206777H, RPS207146H, RPS207520H, RPS208166H, RPS204464H, RPS204776H, RPS207117H, RPS204003H… Full codes in the FDA record | 8602 units |
| Z-1756-2023 | CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators; GTIN CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA220160H, RPA224981H, RPA226922H, RPA226926H, RPA226931H, RPA226935H, RPA226936H, RPA231700H, RPA231701H, RPA231707H, RPA231708H, RPA231711H, RPA235632H, RPA235645H, RPA235649H, RPA240455H, RPA240473H, RPA240476H, RPA240477H, RPA214967H, RPA219025H, RPA220582H, RPA224560H, RPA229904H, RPA230197H, RPA232865H, RPA239124H, RPA240812H, RPA240813H, RPA240814H, RPA240817H, RPA240821H, RPA240822H, RPA240825H, RPA240831H, RPA240834H, RPA240838H, RPA220840H, RPA225194H, RPA233160H, RPA242772H, RPA222022H, RPA222334H, RPA226679H, RPA228141H, RPA228927H, RPA229342H, RPA229425H, RPA240558H, RPA241482H, RPA242003H, RPA242887H, RPA240059H, RPA240830H, RPA242610H, RPA242611H, RPA242695H, RPA242800H, RPA243342H, RPA243356H, RPA243358H, RPA232874H, RPA240168H, RPA208767H, RPA208769H, RPA211496H, RPA212326H, RPA213403H, RPA213430H, RPA215858H, RPA215861H, RPA215864H, RPA222904H, RPA222906H, RPA226778H, RPA231563H, RPA231566H, RPA231568H, RPA232553H, RPA236837H, RPA236840H, RPA236842H, RPA241975H, RPA226862H, RPA241003H, RPA212993H, RPA214389H, RPA214965H, RPA215497H, RPA216355H, RPA217813H, RPA219094H, RPA219114H… Full codes in the FDA record | 58706 units |
| Z-1757-2023 | CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S, RPO604415S, RPO601299S, RPO603042S, RPO604021S, RPO601893S, RPO602016S, RPO603962S, RPO604147S, RPO604306S, RPO604347S, RPO601471S, RPO601485S, RPO601591S, RPO601680S, RPO601738S, RPO601973S, RPO602107S, RPO602217S, RPO602241S… Full codes in the FDA record | 3570 units |
| Z-1758-2023 | CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S, RPD602512S, RPD602649S, RPD602813S, RPD602835S, RPD602924S, RPD603046S, RPD603061S, RPD603062S, RPD603483S, RPD603567S, RPD603785S, RPD603849S, RPD603850S, RPD603860S, RPD603870S, RPD603888S, RPD604408S, RPD604562S, RPD604598S… Full codes in the FDA record | 4593 units |
| Z-1759-2023 | CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators; GTIN 00643169837614, Lot Serial numbers: RPN602297S, RPN602079S, RPN601385S, RPN601320S, RPN601216S, RPN601977S, RPN602107S, RPN600885S, RPN601199S, RPN600682S, RPN601504S, RPN601513S, RPN601653S, RPN601681S, RPN602258S, RPN600961S, RPN600858S, RPN600867S, RPN600868S, RPN600942S, RPN601384S, RPN601398S, RPN601516S, RPN601873S, RPN601874S, RPN602264S, RPN602302S, RPN602350S, RPN602422S, RPN602462S, RPN602468S, RPN602507S, RPN601042S, RPN601529S, RPN602434S, RPN601306S, RPN601439S, RPN602416S, RPN601214S, RPN601763S, RPN601891S, RPN600750S, RPN601165S, RPN600770S, RPN601245S, RPN602186S, RPN602293S, RPN600666S, RPN600683S, RPN601094S, RPN601229S, RPN601277S, RPN601298S, RPN601393S, RPN601662S, RPN602160S, RPN600812S, RPN601674S, RPN602429S, RPN600678S, RPN602335S, RPN602420S, RPN601154S, RPN601660S, RPN602247S, RPN602355S, RPN602463S, RPN600888S, RPN601753S, RPN601619S, RPN600829S, RPN601839S, RPN601845S, RPN602501S, RPN602393S, RPN600717S, RPN600808S, RPN602021S, RPN602251S, RPN602415S, RPN600747S, RPN600985S, RPN601048S, RPN601054S, RPN601160S, RPN601168S, RPN601169S, RPN601530S, RPN601727S, RPN601864S, RPN602075S, RPN602104S, RPN602138S, RPN602161S, RPN602167S, RPN602311S, RPN602457S, RPN602489S, RPN600694S… Full codes in the FDA record | 1658 units |
| Z-1760-2023 | CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S, RPB609639S, RPB609652S, RPB609969S, RPB610019S, RPB610077S, RPB610186S, RPB610230S, RPB610431S, RPB610434S, RPB610437S, RPB610506S, RPB610813S, RPB610882S, RPB610955S, RPB611316S, RPB611327S, RPB611370S, RPB611482S, RPB611609S… Full codes in the FDA record | 23223 units |
| Z-1761-2023 | CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H, RPV205120H, RPV205257H, RPV205259H, RPV205320H, RPV205337H, RPV205356H, RPV205384H, RPV205436H, RPV205442H, RPV205593H, RPV205756H, RPV205775H, RPV205811H, RPV203905H, RPV204228H, RPV204229H, RPV204681H, RPV204682H, RPV204959H… Full codes in the FDA record | 3005 units |
| Z-1762-2023 | CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ205969H, RPJ205051H, RPJ206429H, RPJ205893H, RPJ205344H, RPJ206237H, RPJ206208H, RPJ206032H, RPJ206082H, RPJ206104H, RPJ205080H, RPJ205234H, RPJ206059H, RPJ205438H, RPJ206376H, RPJ205287H, RPJ205509H, RPJ206342H, RPJ205891H, RPJ204872H, RPJ204899H, RPJ204933H, RPJ204973H, RPJ205142H, RPJ205777H, RPJ205989H, RPJ206295H, RPJ205059H, RPJ205148H, RPJ205732H, RPJ205873H, RPJ206504H, RPJ205500H, RPJ206357H, RPJ204876H, RPJ206359H, RPJ206369H, RPJ205623H, RPJ206218H, RPJ205743H, RPJ206172H, RPJ204917H, RPJ205981H, RPJ205041H, RPJ205073H, RPJ205235H, RPJ205246H, RPJ205279H, RPJ206045H, RPJ205880H, RPJ206050H, RPJ206207H, RPJ205049H, RPJ204888H, RPJ205038H, RPJ205039H, RPJ205047H, RPJ205053H, RPJ205054H, RPJ205333H, RPJ205334H, RPJ205349H, RPJ205420H, RPJ205471H, RPJ205510H, RPJ205593H, RPJ205717H, RPJ205727H, RPJ205982H, RPJ206074H, RPJ206186H, RPJ206234H, RPJ204891H, RPJ205317H, RPJ205918H, RPJ205410H, RPJ206238H, RPJ206500H, RPJ204998H, RPJ205089H, RPJ205560H, RPJ205770H, RPJ206389H, RPJ205871H, RPJ205872H, RPJ205876H, RPJ205957H, RPJ206198H, RPJ206199H, RPJ206418H, RPJ206499H, RPJ204956H, RPJ205488H… Full codes in the FDA record | 2767 units |
| Z-1763-2023 | CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators; GTIN 00643169837683, Lot Serial Numbers: RPU202561H, RPU202848H, RPU202573H, RPU203658H, RPU203285H, RPU203317H, RPU203431H, RPU203502H, RPU203716H, RPU203301H, RPU203534H, RPU203203H, RPU203261H, RPU203298H, RPU203066H, RPU203286H, RPU202440H, RPU202452H, RPU202505H, RPU202580H, RPU202588H, RPU202610H, RPU202614H, RPU202616H, RPU202617H, RPU202619H, RPU202624H, RPU202690H, RPU202707H, RPU202829H, RPU202831H, RPU202834H, RPU202914H, RPU203010H, RPU203011H, RPU203012H, RPU203013H, RPU203017H, RPU203018H, RPU203019H, RPU203021H, RPU203159H, RPU203161H, RPU203205H, RPU203486H, RPU203494H, RPU203242H, RPU203690H, RPU203709H, RPU203138H, RPU202362H, RPU202206H, RPU202274H, RPU202493H, RPU202529H, RPU202874H, RPU203234H, RPU203405H, RPU202258H, RPU202269H, RPU202642H, RPU202948H, RPU203105H, RPU203278H, RPU203104H, RPU202960H, RPU202775H, RPU203122H, RPU203648H, RPU202139H, RPU202324H, RPU202745H, RPU202577H, RPU203031H, RPU203300H, RPU202814H, RPU202388H, RPU202818H, RPU203357H, RPU203517H, RPU203676H, RPU203480H, RPU203639H, RPU202382H, RPU203320H, RPU203581H, RPU202260H, RPU202534H, RPU203529H, RPU203733H, RPU202478H, RPU203413H, RPU202601H, RPU202861H, RPU203150H, RPU202884H, RPU202433H, RPU202448H, RPU203699H… Full codes in the FDA record | 2173 units |
| Z-1764-2023 | CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE222453H, RPE222479H, RPE222484H, RPE222493H, RPE223082H, RPE223083H, RPE223085H, RPE223086H, RPE223087H, RPE224112H, RPE224115H, RPE224116H, RPE224117H, RPE221282H, RPE222157H, RPE222778H, RPE222899H, RPE223002H, RPE223681H, RPE222052H, RPE224096H, RPE224699H, RPE225223H, RPE225228H, RPE225260H, RPE226241H, RPE226280H, RPE226296H, RPE226578H, RPE226614H, RPE226861H, RPE227698H, RPE227755H, RPE223791H, RPE226062H, RPE221213H, RPE221541H, RPE221727H, RPE221823H, RPE222060H, RPE222451H, RPE222481H, RPE222548H, RPE222618H, RPE222760H, RPE222970H, RPE222978H, RPE223026H, RPE224464H, RPE224543H, RPE224745H, RPE225324H, RPE225723H, RPE225724H, RPE225729H, RPE225737H, RPE220952H, RPE220957H, RPE220960H, RPE221018H, RPE221039H, RPE221251H, RPE221335H, RPE221336H, RPE222358H, RPE223216H, RPE223219H, RPE224021H, RPE224024H, RPE224026H, RPE224029H, RPE224031H, RPE224032H, RPE224827H, RPE224828H, RPE224829H, RPE224830H, RPE224832H, RPE224833H, RPE224834H, RPE224835H, RPE224836H, RPE224837H, RPE224838H, RPE224840H, RPE224841H, RPE224844H, RPE225172H, RPE221479H, RPE221865H, RPE221947H, RPE222309H, RPE222434H… Full codes in the FDA record | 10370 units |
| Z-1765-2023 | CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837645, Lot Serial numbers: RPQ605053S, RPQ606292S, RPQ605067S, RPQ605093S, RPQ601699S, RPQ605875S, RPQ605881S, RPQ601451S, RPQ602698S, RPQ605503S, RPQ606300S, RPQ601185S, RPQ601351S, RPQ601948S, RPQ601950S, RPQ602093S, RPQ602202S, RPQ602212S, RPQ602402S, RPQ602403S, RPQ602595S, RPQ602960S, RPQ602961S, RPQ602985S, RPQ603049S, RPQ603082S, RPQ603318S, RPQ603408S, RPQ603450S, RPQ605289S, RPQ606079S, RPQ603112S, RPQ603355S, RPQ603428S, RPQ604101S, RPQ604644S, RPQ602479S, RPQ603775S, RPQ604354S, RPQ604567S, RPQ605754S, RPQ605514S, RPQ605535S, RPQ603729S, RPQ605540S, RPQ603758S, RPQ604571S, RPQ605118S, RPQ602683S, RPQ602692S, RPQ602715S, RPQ603495S, RPQ603504S, RPQ603555S, RPQ603644S, RPQ603647S, RPQ604572S, RPQ604621S, RPQ604622S, RPQ604684S, RPQ604686S, RPQ604777S, RPQ604953S, RPQ605095S, RPQ605164S, RPQ605353S, RPQ605428S, RPQ602526S, RPQ602527S, RPQ602702S, RPQ603503S, RPQ604660S, RPQ604880S, RPQ604892S, RPQ604942S, RPQ604951S, RPQ605209S, RPQ602359S, RPQ602686S, RPQ602740S, RPQ604375S, RPQ602680S, RPQ602720S, RPQ602365S, RPQ604944S, RPQ603730S, RPQ604712S, RPQ605182S, RPQ604730S, RPQ602700S, RPQ602713S, RPQ602721S, RPQ604311S, RPQ604941S, RPQ604532S, RPQ602043S, RPQ602834S, RPQ603511S, RPQ603931S… Full codes in the FDA record | 6536 units |
| Z-1766-2023 | CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S, RPK606853S, RPK607088S, RPK607422S, RPK607441S, RPK607442S, RPK607443S, RPK607620S, RPK607647S, RPK607857S, RPK607865S, RPK607972S, RPK608102S, RPK608939S, RPK604642S, RPK604644S, RPK604989S, RPK607684S, RPK608101S, RPK608890S… Full codes in the FDA record | 8575 units |
| Z-1767-2023 | CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators; GTIN 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S, RPP601248S, RPP603177S, RPP603172S, RPP603771S, RPP602869S, RPP601435S, RPP601415S, RPP600928S, RPP601427S, RPP602144S, RPP603032S, RPP603520S, RPP602501S, RPP603038S, RPP601593S, RPP602078S, RPP602304S, RPP602511S, RPP602666S… Full codes in the FDA record | 4767 units |
| Z-1768-2023 | CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720695, Lot Serial numbers: RPG619037S, RPG608482S, RPG611787S, RPG619305S, RPG609628S, RPG622247S, RPG619130S, RPG623603S, RPG610818S, RPG616992S, RPG619816S, RPG624535S, RPG614089S, RPG619704S, RPG619714S, RPG623002S, RPG624602S, RPG607260S, RPG607434S, RPG607977S, RPG608232S, RPG608831S, RPG609415S, RPG609836S, RPG609911S, RPG610009S, RPG610345S, RPG611061S, RPG611302S, RPG611328S, RPG611598S, RPG611600S, RPG611606S, RPG611666S, RPG611667S, RPG611668S, RPG612610S, RPG612884S, RPG612885S, RPG613206S, RPG613239S, RPG613578S, RPG613655S, RPG614353S, RPG614407S, RPG614439S, RPG614898S, RPG615028S, RPG617792S, RPG617839S, RPG618125S, RPG618648S, RPG618809S, RPG618811S, RPG619226S, RPG619228S, RPG619555S, RPG619776S, RPG619888S, RPG619890S, RPG619891S, RPG620540S, RPG620563S, RPG621028S, RPG621106S, RPG621190S, RPG621228S, RPG621272S, RPG621395S, RPG621680S, RPG621722S, RPG621724S, RPG621725S, RPG621730S, RPG621743S, RPG622038S, RPG622041S, RPG622085S, RPG622532S, RPG622533S, RPG622881S, RPG622905S, RPG622984S, RPG623287S, RPG623393S, RPG623681S, RPG623684S, RPG623693S, RPG624227S, RPG624640S, RPG624641S, RPG624699S, RPG624702S, RPG625103S, RPG625298S, RPG625299S, RPG625307S, RPG625310S, RPG625343S… Full codes in the FDA record | 28172 units |
| Z-1769-2023 | CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators; GTIN 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW201002H, RPW201095H, RPW200917H, RPW201040H, RPW201026H, RPW200661H, RPW200981H, RPW200665H, RPW200741H, RPW200743H, RPW200908H, RPW200971H, RPW200600H, RPW200635H, RPW200638H, RPW200652H, RPW200657H, RPW200660H, RPW200761H, RPW200800H, RPW200803H, RPW200822H, RPW200827H, RPW200714H, RPW200809H, RPW200548H, RPW201023H, RPW201103H, RPW200575H, RPW200794H, RPW200807H, RPW200994H, RPW201055H, RPW200630H, RPW200659H, RPW200904H, RPW201079H, RPW201171H, RPW200578H, RPW200695H, RPW200621H, RPW201015H, RPW201084H, RPW201151H, RPW201153H, RPW200590H, RPW200938H, RPW200582H, RPW200847H, RPW200870H, RPW200683H, RPW200685H, RPW200754H, RPW200852H, RPW200585H, RPW200648H, RPW200669H, RPW200673H, RPW200721H, RPW200839H, RPW200879H, RPW200882H, RPW201041H, RPW201140H, RPW201161H, RPW200692H, RPW200863H, RPW200881H, RPW200969H, RPW201032H, RPW200553H, RPW200543H, RPW200595H, RPW200686H, RPW200698H, RPW200738H, RPW200750H, RPW200753H, RPW200804H, RPW200813H, RPW200838H, RPW200894H, RPW201133H, RPW200556H, RPW200855H, RPW200626H, RPW200646H, RPW200711H, RPW201080H, RPW200577H, RPW201088H, RPW200653H, RPW200605H… Full codes in the FDA record | 664 units |
| Z-1770-2023 | CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720749, Lot Serial Numbers: RPL202320H, RPL202797H, RPL202825H, RPL203304H, RPL203279H, RPL203319H, RPL203730H, RPL203754H, RPL204075H, RPL202479H, RPL202565H, RPL202842H, RPL203342H, RPL203518H, RPL203521H, RPL203522H, RPL203534H, RPL203543H, RPL203556H, RPL203602H, RPL203718H, RPL203723H, RPL203785H, RPL203210H, RPL202222H, RPL202318H, RPL202555H, RPL202697H, RPL202831H, RPL203172H, RPL202156H, RPL202223H, RPL202514H, RPL203290H, RPL203308H, RPL203446H, RPL202803H, RPL202347H, RPL202465H, RPL202684H, RPL202688H, RPL202707H, RPL202934H, RPL202972H, RPL203031H, RPL203078H, RPL203345H, RPL203399H, RPL203581H, RPL203623H, RPL203688H, RPL202382H, RPL202497H, RPL202590H, RPL203217H, RPL203225H, RPL203363H, RPL203369H, RPL203428H, RPL203479H, RPL203480H, RPL203484H, RPL203487H, RPL203488H, RPL203500H, RPL203513H, RPL203569H, RPL203794H, RPL202376H, RPL202499H, RPL202905H, RPL202940H, RPL203030H, RPL203784H, RPL203795H, RPL203957H, RPL202146H, RPL202538H, RPL202681H, RPL202892H, RPL202973H, RPL203164H, RPL202397H, RPL203253H, RPL203407H, RPL202200H, RPL202294H, RPL202834H, RPL202859H, RPL203075H, RPL203077H, RPL203104H, RPL203388H, RPL203560H, RPL203567H, RPL203574H, RPL203620H, RPL203670H, RPL202172H… Full codes in the FDA record | — |
| Z-1771-2023 | CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837652, Lot Serial Numbers: RPR605458S, RPR606698S, RPR605664S, RPR602262S, RPR601954S, RPR602352S, RPR602691S, RPR602236S, RPR601128S, RPR601184S, RPR601760S, RPR603209S, RPR603275S, RPR603699S, RPR605742S, RPR605761S, RPR605767S, RPR605779S, RPR605784S, RPR605787S, RPR605804S, RPR605808S, RPR605811S, RPR605818S, RPR606116S, RPR606117S, RPR606122S, RPR606123S, RPR606127S, RPR606128S, RPR606138S, RPR606140S, RPR606272S, RPR606276S, RPR606278S, RPR606279S, RPR606285S, RPR606289S, RPR607179S, RPR607180S, RPR607181S, RPR607182S, RPR607183S, RPR607184S, RPR607185S, RPR607187S, RPR607188S, RPR607525S, RPR606331S, RPR607064S, RPR607604S, RPR607373S, RPR604676S, RPR605390S, RPR605391S, RPR607439S, RPR602589S, RPR602608S, RPR602612S, RPR602645S, RPR602882S, RPR602940S, RPR602941S, RPR602944S, RPR602946S, RPR602951S, RPR603067S, RPR603252S, RPR603254S, RPR603744S, RPR603758S, RPR603759S, RPR603891S, RPR603892S, RPR603894S, RPR604007S, RPR604025S, RPR604173S, RPR604233S, RPR604234S, RPR604235S, RPR604236S, RPR604237S, RPR604238S, RPR604302S, RPR604308S, RPR604320S, RPR604326S, RPR604354S, RPR604559S, RPR604560S, RPR604678S, RPR604679S, RPR604681S, RPR605666S, RPR605668S, RPR605899S, RPR605970S, RPR605971S… Full codes in the FDA record | 10197 units |
| Z-1772-2023 | CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720701, Lot Serial Numbers: RPH603922S, RPH608147S, RPH603531S, RPH607413S, RPH607373S, RPH604394S, RPH606758S, RPH603572S, RPH606941S, RPH603152S, RPH603203S, RPH603999S, RPH604021S, RPH606976S, RPH603841S, RPH604928S, RPH605779S, RPH605780S, RPH606559S, RPH606577S, RPH606694S, RPH606731S, RPH606795S, RPH607014S, RPH607015S, RPH607016S, RPH607157S, RPH607244S, RPH607443S, RPH607748S, RPH608114S, RPH607674S, RPH607675S, RPH607677S, RPH607681S, RPH607688S, RPH609399S, RPH607884S, RPH608003S, RPH608138S, RPH608464S, RPH608655S, RPH608676S, RPH608835S, RPH608853S, RPH608950S, RPH608952S, RPH608958S, RPH609021S, RPH609279S, RPH609280S, RPH609281S, RPH609282S, RPH607432S, RPH609308S, RPH607753S, RPH603849S, RPH603912S, RPH603913S, RPH604139S, RPH604140S, RPH604142S, RPH604266S, RPH604267S, RPH604268S, RPH604435S, RPH604692S, RPH604708S, RPH604785S, RPH605048S, RPH605058S, RPH605167S, RPH605790S, RPH605824S, RPH605882S, RPH606393S, RPH606447S, RPH606491S, RPH606568S, RPH607305S, RPH607306S, RPH607412S, RPH607414S, RPH607568S, RPH607801S, RPH607969S, RPH607970S, RPH608423S, RPH608424S, RPH608644S, RPH609447S, RPH609514S, RPH604243S, RPH602654S, RPH603493S, RPH603502S, RPH607247S, RPH607311S, RPH609270S… Full codes in the FDA record | 11375 units |
| Z-1773-2023 | CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators; GTIN 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S, RPF613377S, RPF613378S, RPF613422S, RPF613858S, RPF613859S, RPF613860S, RPF613861S, RPF613862S, RPF613864S, RPF613865S, RPF613866S, RPF613867S, RPF613868S, RPF613869S, RPF613870S, RPF613874S, RPF613876S, RPF613881S, RPF613885S… Full codes in the FDA record | 31884 units |
| Z-1774-2023 | CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators; GTIN 00763000178147, Lot Serial numbers: RTH601483S, RTH602021S, RTH602022S, RTH602302S, RTH602303S, RTH602305S, RTH602306S, RTH605169S, RTH602089S, RTH603993S, RTH601526S, RTH600467S, RTH600514S, RTH600533S, RTH600607S, RTH600608S, RTH601387S, RTH601543S, RTH601544S, RTH601545S, RTH602017S, RTH605116S, RTH600520S, RTH602108S, RTH604790S, RTH602149S, RTH605081S, RTH605082S, RTH604360S, RTH604780S, RTH604943S, RTH604734S, RTH600153S, RTH601390S, RTH601395S, RTH601849S, RTH601868S, RTH602192S, RTH602619S, RTH600554S, RTH602035S, RTH602694S, RTH600170S, RTH602206S, RTH601611S, RTH602091S, RTH602195S, RTH603628S, RTH600220S, RTH600223S, RTH600228S, RTH600288S, RTH601447S, RTH601448S, RTH601449S, RTH601450S, RTH602055S, RTH602056S, RTH602057S, RTH602058S, RTH602059S, RTH602060S, RTH602061S, RTH602064S, RTH602065S, RTH602067S, RTH602069S, RTH602071S, RTH602072S, RTH602073S, RTH602074S, RTH602077S, RTH602078S, RTH602079S, RTH602271S, RTH602272S, RTH602276S, RTH602277S, RTH602288S, RTH602625S, RTH602626S, RTH602627S, RTH602628S, RTH602629S, RTH602630S, RTH602631S, RTH602632S, RTH602633S, RTH602634S, RTH602635S, RTH602639S, RTH602640S, RTH602641S, RTH602642S, RTH602643S, RTH602645S, RTH602646S, RTH603959S, RTH603977S… Full codes in the FDA record | 4151 units |
| Z-1775-2023 | CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators; GTIN 00763000501044, lot serial Numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, RTH602442S | 5 units |
| Z-1776-2023 | CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators; GTIN 00763000446048, lot serial Numbers: RTH601150S, RTH601151S; GTIN 00763000718732, Lot Serial Numbers: RTH603584S | 3 units |
| Z-1777-2023 | CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators; GTIN 00763000178130, Lot Serial Numbers: RTG605297S, RTG605299S, RTG600588S, RTG601635S, RTG601691S, RTG601840S, RTG601857S, RTG602986S, RTG601966S, RTG601364S, RTG601621S, RTG600270S, RTG600554S, RTG601405S, RTG601699S, RTG601977S, RTG605270S, RTG600137S, RTG600138S, RTG600181S, RTG600271S, RTG600618S, RTG600620S, RTG600621S, RTG600622S, RTG600640S, RTG601395S, RTG601441S, RTG601681S, RTG601783S, RTG601896S, RTG601945S, RTG601948S, RTG602037S, RTG602040S, RTG602042S, RTG602047S, RTG602165S, RTG602166S, RTG602167S, RTG602340S, RTG605614S, RTG602039S, RTG602228S, RTG602306S, RTG602477S, RTG605996S, RTG605997S, RTG604903S, RTG600228S, RTG600332S, RTG601906S, RTG602441S, RTG605330S, RTG605332S, RTG605838S, RTG601643S, RTG606091S, RTG600317S, RTG600255S, RTG600467S, RTG604871S, RTG605042S, RTG605051S, RTG606010S, RTG601452S, RTG602204S, RTG604466S, RTG600411S, RTG600412S, RTG600465S, RTG600517S, RTG602559S, RTG602561S, RTG602563S, RTG602565S, RTG602566S, RTG602569S, RTG602571S, RTG602573S, RTG603385S, RTG603386S, RTG603400S, RTG603404S, RTG605218S, RTG601409S, RTG601410S, RTG601525S, RTG601863S, RTG601870S, RTG603636S, RTG603637S, RTG603684S, RTG605663S, RTG601684S, RTG600188S, RTG601614S, RTG602242S, RTG600594S… Full codes in the FDA record | 1914 units |
| Z-1778-2023 | CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators; GTIN 00763000178109, Lot Serial numbers: RTD602437S, RTD602300S, RTD602301S, RTD602414S, RTD602417S, RTD602418S, RTD602419S, RTD601286S, RTD600407S, RTD600686S, RTD600687S, RTD600688S, RTD600689S, RTD601807S, RTD602096S, RTD602321S, RTD601977S, RTD600375S, RTD600427S, RTD600818S, RTD601290S, RTD601294S, RTD601304S, RTD603210S, RTD601610S, RTD601791S, RTD600469S, RTD601931S, RTD601498S, RTD601499S, RTD601778S, RTD602158S, RTD602232S, RTD602015S, RTD602249S, RTD603182S, RTD601298S, RTD600498S, RTD603371S, RTD600756S, RTD602093S, RTD601471S, RTD601517S, RTD601525S, RTD601526S, RTD601532S, RTD601534S, RTD601535S, RTD601551S, RTD601552S, RTD601843S, RTD601844S, RTD601846S, RTD601849S, RTD601851S, RTD601852S, RTD601853S, RTD601855S, RTD601857S, RTD601858S, RTD601859S, RTD601861S, RTD601862S, RTD601878S, RTD601895S, RTD601907S, RTD601913S, RTD601914S, RTD601915S, RTD601916S, RTD601933S, RTD601935S, RTD601936S, RTD601937S, RTD601942S, RTD601985S, RTD602052S, RTD602053S, RTD602054S, RTD602055S, RTD602056S, RTD602058S, RTD602059S, RTD602060S, RTD602061S, RTD602062S, RTD602063S, RTD602064S, RTD602065S, RTD602066S, RTD602067S, RTD602272S, RTD602273S, RTD602274S, RTD602276S, RTD602278S, RTD602279S, RTD602280S, RTD602281S… Full codes in the FDA record | 2669 units |
| Z-1779-2023 | CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators; GTIN 00763000178093, Lot Serial Numbers: RTC605498S, RTC605500S, RTC605501S, RTC605502S, RTC607884S, RTC607885S, RTC608196S, RTC608199S, RTC608200S, RTC610884S, RTC610885S, RTC610887S, RTC610889S, RTC610890S, RTC610892S, RTC626989S, RTC626991S, RTC626992S, RTC626996S, RTC604820S, RTC605664S, RTC606411S, RTC606605S, RTC613019S, RTC613629S, RTC614078S, RTC612708S, RTC614277S, RTC611123S, RTC611127S, RTC611128S, RTC613158S, RTC613159S, RTC613160S, RTC613162S, RTC613164S, RTC613165S, RTC613166S, RTC626776S, RTC626778S, RTC626780S, RTC612365S, RTC612540S, RTC612629S, RTC614220S, RTC600235S, RTC600300S, RTC600381S, RTC600573S, RTC602541S, RTC602726S, RTC605274S, RTC605795S, RTC607215S, RTC607469S, RTC608981S, RTC609490S, RTC610107S, RTC610867S, RTC613560S, RTC614081S, RTC600433S, RTC600555S, RTC600556S, RTC600576S, RTC600703S, RTC604519S, RTC605238S, RTC605983S, RTC606093S, RTC606096S, RTC607001S, RTC607069S, RTC607165S, RTC607228S, RTC607497S, RTC609933S, RTC609934S, RTC614263S, RTC616913S, RTC626571S, RTC626741S, RTC626744S, RTC600227S, RTC600446S, RTC600738S, RTC602429S, RTC602521S, RTC602532S, RTC602562S, RTC602581S, RTC602606S, RTC602647S, RTC602760S, RTC603157S, RTC604487S, RTC604489S, RTC604490S, RTC604517S… Full codes in the FDA record | 27788 Units |
| Z-1780-2023 | ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators; GTIN 00763000501020, Lot Serial Numbers: RTC614024S, RTC617998S, RTC614026S, RTC617999S, RTC618002S, RTC618007S, RTC621332S, RTC614023S, RTC611661S | 9 units |
| Z-1781-2023 | CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators; GTIN 00763000178222, Lot Serial numbers: RTP600502S, RTP602448S, RTP600549S, RTP600551S, RTP600553S, RTP600554S, RTP600555S, RTP601566S, RTP601569S, RTP602731S, RTP602733S, RTP601785S, RTP601786S, RTP601825S, RTP601826S, RTP601620S, RTP602203S, RTP602327S, RTP600744S, RTP600745S, RTP600762S, RTP601117S, RTP601187S, RTP601231S, RTP601906S, RTP603519S, RTP600475S, RTP600228S, RTP600308S, RTP600757S, RTP601116S, RTP601219S, RTP601221S, RTP601723S, RTP601724S, RTP601907S, RTP602117S, RTP602216S, RTP601572S, RTP602154S, RTP602038S, RTP600454S, RTP600670S, RTP601041S, RTP601066S, RTP601209S, RTP601801S, RTP600394S, RTP600397S, RTP600184S, RTP601049S, RTP601072S, RTP601822S, RTP600645S, RTP603289S, RTP603604S, RTP600559S, RTP600796S, RTP601834S, RTP600396S, RTP600738S, RTP600739S, RTP600740S, RTP600741S, RTP601589S, RTP601591S, RTP601595S, RTP601596S, RTP600148S, RTP600700S, RTP600627S, RTP601567S, RTP601186S, RTP601999S, RTP600819S, RTP601857S, RTP600576S, RTP600585S, RTP600779S, RTP600829S, RTP600452S, RTP601850S, RTP602030S, RTP602285S, RTP603440S, RTP600773S, RTP600498S, RTP600970S, RTP602267S, RTP602292S, RTP601227S, RTP600896S, RTP601034S, RTP601035S, RTP602213S, RTP602271S, RTP600671S, RTP600675S, RTP601862S… Full codes in the FDA record | 2884 units |
| Z-1782-2023 | CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators; GTIN 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S, RTO600716S, RTO600464S, RTO601650S, RTO600151S, RTO600363S, RTO601008S, RTO600267S, RTO600268S, RTO600571S, RTO600605S, RTO600640S, RTO602065S, RTO600244S, RTO600634S, RTO602301S, RTO602309S, RTO600283S, RTO601834S, RTO602047S… Full codes in the FDA record | 2968 units |
| Z-1783-2023 | CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators; GTIN 00763000178185, Lot Serial Numbers: RTL600234S, RTL600470S, RTL601046S, RTL601412S, RTL601722S, RTL601669S, RTL601698S, RTL600323S, RTL600660S, RTL600661S, RTL601185S, RTL601206S, RTL601213S, RTL601406S, RTL601445S, RTL601446S, RTL600649S, RTL600650S, RTL601428S, RTL601017S, RTL600219S, RTL601076S, RTL601544S, RTL602514S, RTL600684S, RTL601477S, RTL601865S, RTL600638S, RTL600639S, RTL600640S, RTL600641S, RTL600642S, RTL600643S, RTL601151S, RTL601154S, RTL601156S, RTL601160S, RTL601161S, RTL601162S, RTL601163S, RTL601164S, RTL601165S, RTL601167S, RTL601170S, RTL600209S, RTL600835S, RTL600997S, RTL600519S, RTL601459S, RTL601689S, RTL600978S, RTL601540S, RTL601880S, RTL600522S, RTL601510S, RTL600949S, RTL601624S, RTL601372S, RTL600810S, RTL600266S, RTL600281S, RTL600528S, RTL600596S, RTL600654S, RTL600777S, RTL600813S, RTL600841S, RTL600846S, RTL601563S, RTL601021S, RTL601208S, RTL600243S, RTL600244S, RTL600245S, RTL600533S, RTL601085S, RTL601148S, RTL601373S, RTL601231S, RTL601864S, RTL601607S, RTL600270S, RTL600499S, RTL600755S, RTL601441S, RTL601475S, RTL601575S, RTL601804S, RTL601278S, RTL600794S, RTL600844S, RTL601143S, RTL601144S, RTL600960S, RTL601470S, RTL601082S, RTL601289S, RTL601291S, RTL601584S… Full codes in the FDA record | 1878 units |
| Z-1784-2023 | CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators; GTIN 00763000178178, Lot Serial numbers: RTK605097S, RTK600114S, RTK600141S, RTK600852S, RTK600858S, RTK601106S, RTK601201S, RTK602089S, RTK602953S, RTK603591S, RTK604031S, RTK600525S, RTK602527S, RTK606714S, RTK608837S, RTK608930S, RTK610777S, RTK600938S, RTK600939S, RTK600940S, RTK601391S, RTK601392S, RTK601393S, RTK601395S, RTK604983S, RTK604984S, RTK604033S, RTK606189S, RTK606293S, RTK606647S, RTK606683S, RTK606985S, RTK606988S, RTK607188S, RTK607189S, RTK607190S, RTK607191S, RTK607242S, RTK610835S, RTK603685S, RTK605333S, RTK601363S, RTK602275S, RTK602876S, RTK603055S, RTK600536S, RTK603273S, RTK603414S, RTK603912S, RTK604677S, RTK602444S, RTK602532S, RTK602533S, RTK602534S, RTK603360S, RTK603873S, RTK603874S, RTK603875S, RTK604155S, RTK604215S, RTK604626S, RTK607991S, RTK604065S, RTK604500S, RTK604161S, RTK610478S, RTK601877S, RTK606247S, RTK600611S, RTK609287S, RTK609288S, RTK609289S, RTK609290S, RTK609291S, RTK609293S, RTK609294S, RTK609295S, RTK609296S, RTK600247S, RTK600372S, RTK600622S, RTK601085S, RTK601214S, RTK602561S, RTK603534S, RTK603779S, RTK603793S, RTK603825S, RTK604693S, RTK604866S, RTK606038S, RTK609026S, RTK611004S, RTK617383S, RTK617202S, RTK605241S, RTK606999S, RTK609748S, RTK605348S… Full codes in the FDA record | 15427 units |
| Z-1785-2023 | CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators; GTIN 00763000178307, Lot Serial numbers: RTX600076S, RTX600084S, RTX600139S, RTX600148S, RTX600114S, RTX600308S, RTX600386S, RTX600327S, RTX600334S, RTX600372S, RTX600046S, RTX600048S, RTX600066S, RTX600108S, RTX600261S, RTX600345S, RTX600586S, RTX600382S, RTX600388S, RTX600064S, RTX600069S, RTX600096S, RTX600377S, RTX600360S, RTX600581S, RTX600158S, RTX600306S, RTX600713S, RTX600100S, RTX600319S, RTX600594S, RTX600720S, RTX600727S, RTX600045S, RTX600153S, RTX600157S, RTX600326S, RTX600081S, RTX600146S, RTX600055S, RTX600058S, RTX600143S, RTX600314S, RTX600323S, RTX600332S, RTX600344S, RTX600693S, RTX600307S, RTX600310S, RTX600317S, RTX600588S, RTX600705S, RTX600072S, RTX600095S, RTX600147S, RTX600695S, RTX600698S, RTX600309S, RTX600792S, RTX600167S, RTX600807S, RTX600387S, RTX600086S, RTX600322S, RTX600343S, RTX600365S, RTX600091S, RTX600124S, RTX600597S, RTX600688S, RTX600689S, RTX600799S, RTX600800S, RTX600085S, RTX600087S, RTX600312S, RTX600019S, RTX600120S, RTX600137S, RTX600260S, RTX600370S, RTX600391S, RTX600724S, RTX600149S, RTX600596S, RTX600159S, RTX600700S, RTX600692S, RTX600170S, RTX600697S, RTX600587S, RTX600330S, RTX600256S, RTX600369S, RTX600394S, RTX600398S, RTX600591S, RTX600592S, RTX600690S, RTX600350S… Full codes in the FDA record | 462 units |
| Z-1786-2023 | CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators; GTIN 00763000178291, Lot Serial numbers: RTW600585S, RTW600307S, RTW600091S, RTW600313S, RTW600121S, RTW600342S, RTW600596S, RTW600074S, RTW600144S, RTW600102S, RTW600319S, RTW600578S, RTW600346S, RTW600277S, RTW600309S, RTW600581S, RTW600098S, RTW600118S, RTW600119S, RTW600123S, RTW600133S, RTW600138S, RTW600159S, RTW600168S, RTW600205S, RTW600052S, RTW600067S, RTW600217S, RTW600333S, RTW600592S, RTW600059S, RTW600151S, RTW600169S, RTW600196S, RTW600229S, RTW600304S, RTW600306S, RTW600223S, RTW600062S, RTW600171S, RTW600049S, RTW600057S, RTW600126S, RTW600130S, RTW600153S, RTW600158S, RTW600163S, RTW600181S, RTW600182S, RTW600188S, RTW600204S, RTW600211S, RTW600230S, RTW600240S, RTW600245S, RTW600247S, RTW600249S, RTW600250S, RTW600317S, RTW600323S, RTW600338S, RTW600588S, RTW600589S, RTW600593S, RTW600339S, RTW600819S, RTW600113S, RTW600594S, RTW600120S, RTW600244S, RTW600008S, RTW600056S, RTW600089S, RTW600183S, RTW600239S, RTW600292S, RTW600297S, RTW600069S, RTW600148S, RTW600080S, RTW600156S, RTW600179S, RTW600094S, RTW600127S, RTW600161S, RTW600813S, RTW600068S, RTW600110S, RTW600149S, RTW600237S, RTW600345S, RTW600591S, RTW600082S, RTW600087S, RTW600090S, RTW600350S, RTW600358S, RTW600362S, RTW600363S, RTW600365S… Full codes in the FDA record | 476 units |
| Z-1787-2023 | CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators; GTIN 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S, RTT600425S, RTT600081S, RTT600035S, RTT600527S, RTT600087S, RTT600433S, RTT600140S, RTT600167S, RTT600168S, RTT600089S, RTT600103S, RTT600030S, RTT600061S, RTT600420S, RTT600566S, RTT600567S; GTIN 00763000178284, Lot Serial Numbers… Full codes in the FDA record | 404 units |
| Z-1788-2023 | CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators; GTIN 00763000178253, Lot Serial Numbers: RTS600109S, RTS600115S, RTS600751S, RTS600754S, RTS600962S, RTS600827S, RTS600976S, RTS600761S, RTS600116S, RTS600128S, RTS600174S, RTS600280S, RTS600285S, RTS600674S, RTS600094S, RTS600271S, RTS600277S, RTS600961S, RTS600987S, RTS601452S, RTS600164S, RTS600168S, RTS600203S, RTS600209S, RTS600222S, RTS600375S, RTS600636S, RTS600652S, RTS600734S, RTS600800S, RTS600876S, RTS600127S, RTS600189S, RTS600170S, RTS600171S, RTS600251S, RTS600459S, RTS600460S, RTS600464S, RTS600537S, RTS600608S, RTS600792S, RTS601104S, RTS601108S, RTS600087S, RTS600091S, RTS601032S, RTS600079S, RTS600080S, RTS600081S, RTS600083S, RTS600119S, RTS600161S, RTS600255S, RTS600258S, RTS600261S, RTS600316S, RTS600322S, RTS600418S, RTS600812S, RTS601439S, RTS601440S, RTS601454S, RTS600198S, RTS600744S, RTS600831S, RTS600843S, RTS600963S, RTS600984S, RTS600989S, RTS601015S, RTS601016S, RTS601434S, RTS601436S, RTS602647S, RTS600836S, RTS600092S, RTS600135S, RTS600136S, RTS600137S, RTS600172S, RTS600181S, RTS600224S, RTS600231S, RTS600246S, RTS600256S, RTS600264S, RTS600342S, RTS600377S, RTS600384S, RTS600385S, RTS600398S, RTS600399S, RTS600424S, RTS600430S, RTS600435S, RTS600442S, RTS600470S, RTS600599S… Full codes in the FDA record | 2142 units |
| Z-1789-2023 | ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169720619, Lot Serial Numbers: BWN203363H, BWN203588H, BWN203428H, BWN203504H, BWN203530H, BWN203214H, BWN203258H, BWN203259H, BWN203304H, BWN203477H, BWN203665H, BWN203423H, BWN203403H, BWN203327H, BWN203518H, BWN203790H, BWN203174H, BWN203624H, BWN203750H, BWN203763H, BWN203786H, BWN203745H, BWN203526H, BWN203813H, BWN203168H, BWN203236H, BWN203374H, BWN203463H, BWN203640H, BWN203213H, BWN203431H, BWN203492H, BWN203585H, BWN203436H, BWN203524H, BWN203528H, BWN203809H, BWN203432H, BWN203231H, BWN203199H, BWN203163H, BWN203193H, BWN203306H, BWN203310H, BWN203352H, BWN203373H, BWN203433H, BWN203575H, BWN203611H, BWN203616H, BWN203689H, BWN203732H, BWN203739H, BWN203749H, BWN203796H, BWN203799H, BWN203803H, BWN203181H, BWN203642H, BWN203202H, BWN203758H, BWN203671H, BWN203769H, BWN203357H, BWN203248H, BWN203253H, BWN203448H, BWN203664H, BWN203733H, BWN203260H, BWN203347H, BWN203408H, BWN203422H, BWN203535H, BWN203582H, BWN203712H, BWN203770H, BWN203697H, BWN203205H, BWN203410H, BWN203590H, BWN203332H, BWN203381H, BWN203430H, BWN203511H, BWN203737H, BWN203355H, BWN203703H, BWN203625H, BWN203380H, BWN203498H, BWN203620H, BWN203622H, BWN203810H, BWN203681H, BWN203685H, BWN203434H, BWN203653H, BWN203564H… Full codes in the FDA record | 425 units |
| Z-1790-2023 | ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H… Full codes in the FDA record | 240 units |
| Z-1791-2023 | ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR600959S, BWR601046S, BWR600938S, BWR601096S, BWR601093S, BWR600979S, BWR601092S, BWR600997S, BWR600934S, BWR600965S, BWR601050S, BWR601049S, BWR600823S, BWR601053S, BWR600983S, BWR600989S, BWR600984S, BWR601055S, BWR601057S, BWR601098S, BWR600822S, BWR600980S, BWR600981S, BWR600982S, BWR601097S, BWR601100S, BWR601095S, BWR601101S, BWR600991S, BWR601051S, BWR601058S, BWR601099S, BWR601094S; GTIN BWR601149S, BWR601155S, BWR601137S, BWR601138S, BWR601108S, BWR601113S, BWR601111S, BWR601119S, BWR601144S, BWR601146S, BWR601147S, BWR601148S, BWR601067S, BWR601150S, BWR601152S, BWR601115S, BWR601105S, BWR601112S, BWR601059S, BWR601061S, BWR601062S, BWR601063S, BWR601072S, BWR601073S, BWR601078S, BWR601081S, BWR601090S, BWR601116S, BWR601103S, BWR601075S, BWR601102S, BWR601104S | 71 units |
| Z-1792-2023 | ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720763, Lot Serial Numbers: BWT600023S, BWT600013S, BWT600014S, BWT600025S, BWT600029S, BWT600030S, BWT600032S, BWT600033S, BWT600034S, BWT600024S,; GTIN 00763000052706, Lot Serial Numbers: BWT600040S, BWT600038S | 12 units |
| Z-1793-2023 | ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169720770, Lot Serial numbers: BWU600672S, BWU600685S, BWU600654S, BWU600656S, BWU600555S, BWU600638S, BWU600641S, BWU600642S, BWU600647S, BWU600648S, BWU600650S, BWU600651S, BWU600664S, BWU600643S, BWU600645S, BWU600557S, BWU600556S, BWU600763S, BWU600640S, BWU600639S, BWU600649S, BWU600661S, BWU600662S, BWU600663S, BWU600665S, BWU600666S, BWU600671S, BWU600673S, BWU600676S, BWU600646S, BWU600652S, BWU600653S, BWU600655S, BWU600658S, BWU600659S, BWU600667S, BWU600668S, BWU600669S, BWU600684S, BWU600694S, BWU600695S, BWU600696S, BWU600697S, BWU600698S, BWU600699S, BWU600700S, BWU600701S, BWU600702S, BWU600703S, BWU600707S, BWU600708S, BWU600709S, BWU600710S, BWU600711S, BWU600714S, BWU600715S, BWU600716S, BWU600739S, BWU600741S, BWU600758S, BWU600760S, BWU600761S, BWU600762S, BWU600764S, BWU600765S, BWU600766S, BWU600712S, BWU600644S; GTIN 00763000052713, Lot Numbers: BWU600776S, BWU600721S, BWU600810S, BWU600771S, BWU600772S, BWU600774S, BWU600723S, BWU600795S, BWU600820S, BWU600720S, BWU600782S, BWU600768S, BWU600719S, BWU600793S, BWU600717S, BWU600718S, BWU600722S, BWU600726S, BWU600727S, BWU600728S, BWU600729S, BWU600730S, BWU600735S, BWU600778S, BWU600807S, BWU600808S, BWU600809S, BWU600813S… Full codes in the FDA record | 176 units |
| Z-1794-2023 | ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720787, Lot Serial Numbers: BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV600024S, BWV600027S, BWV600031S, BWV600032S, BWV600041S, BWV600042S, BWV600043S, BWV600044S, BWV600045S, BWV600046S, BWV600047S, BWV600068S, BWV600069S, BWV600070S, BWV600071S, BWV600072S, BWV600073S, BWV600074S, BWV600087S, BWV600088S, BWV600089S, BWV600090S, BWV600099S, BWV600101S, BWV600105S, BWV600107S, BWV600108S, BWV600109S, BWV600110S, BWV600111S, BWV600112S, BWV600113S, BWV600114S, BWV600115S, BWV600155S, BWV600157S, BWV600160S, BWV600161S, BWV600162S, BWV600163S, BWV600164S, BWV600165S, BWV600166S, BWV600167S, BWV600168S, BWV600170S, BWV600171S, BWV600172S, BWV600173S, BWV600174S, BWV600175S, BWV600176S, BWV600177S, BWV600178S, BWV600179S, BWV600180S, BWV600181S, BWV600183S, BWV600184S, BWV600185S, BWV600186S, BWV600187S, BWV600022S, BWV600025S, BWV600026S, BWV600028S, BWV600029S, BWV600030S, BWV600033S, BWV600034S, BWV600035S, BWV600036S, BWV600037S, BWV600038S, BWV600039S, BWV600040S, BWV600048S, BWV600049S, BWV600050S, BWV600055S, BWV600056S, BWV600057S, BWV600058S, BWV600059S, BWV600060S, BWV600061S, BWV600062S, BWV600063S, BWV600064S, BWV600065S, BWV600066S, BWV600067S, BWV600080S… Full codes in the FDA record | 194 units |
| Z-1795-2023 | ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169720466, Lot Serial Numbers: BWI218211H, BWI218218H, BWI218226H, BWI218228H, BWI218206H, BWI218224H, BWI218210H, BWI218222H, BWI218217H, BWI218214H, BWI218216H, BWI218208H, BWI218207H, BWI218221H, BWI218212H, BWI218220H | 16 units |
| Z-1796-2023 | ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720435, Lot Serial Number: BWH224619H, BWH224621H, BWH224620H, BWH224623H | 4 units |
| Z-1797-2023 | ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169218017, Lot Serial numbers: BWK607537S, BWK607358S, BWK607401S, BWK607460S, BWK607496S, BWK607540S, BWK607351S, BWK607371S, BWK607254S, BWK607394S, BWK607446S, BWK607457S, BWK607473S, BWK607498S, BWK607503S, BWK607536S, BWK607381S, BWK607393S, BWK607369S, BWK607474S, BWK607432S, BWK607439S, BWK607523S, BWK607448S, BWK607526S, BWK607383S, BWK607434S, BWK607463S, BWK607360S, BWK607437S, BWK607472S, BWK607451S, BWK607449S, BWK607436S, BWK607527S, BWK607361S, BWK607275S, BWK607326S, BWK607343S, BWK607384S, BWK607391S, BWK607479S, BWK607501S, BWK607507S, BWK607508S, BWK607518S, BWK607520S, BWK607535S, BWK607544S, BWK607327S, BWK607379S, BWK607521S, BWK607382S, BWK607502S, BWK607366S, BWK607386S, BWK607441S, BWK607468S, BWK607497S, BWK607465S, BWK607455S, BWK607470S, BWK607376S, BWK607529S, BWK607456S, BWK607509S, BWK607505S, BWK607378S, BWK607444S, BWK607297S, BWK607348S, BWK607447S, BWK607395S, BWK607464S, BWK607485S, BWK607534S, BWK607442S, BWK607347S, BWK607389S, BWK607400S, BWK607370S, BWK607438S, BWK607323S, BWK607495S, BWK607519S, BWK607368S, BWK607278S, BWK607433S, BWK607367S, BWK607499S, BWK607349S, BWK607356S, BWK607440S, BWK607458S, BWK607517S, BWK607459S, BWK607392S, BWK607450S, BWK607466S… Full codes in the FDA record | 1354 units |
| Z-1798-2023 | ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169218024, Lot Serial Numbers: BWJ607141S, BWJ607132S, BWJ607040S, BWJ607055S, BWJ607056S, BWJ607025S; GTIN 00643169969575, Lot Serial Numbers: BWJ607007S, BWJ607008S, BWJ607010S, BWJ607011S, BWJ607012S, BWJ607015S, BWJ607020S, BWJ607022S, BWJ607024S, BWJ607029S, BWJ607034S, BWJ607035S, BWJ607037S, BWJ607077S, BWJ607347S, BWJ607043S, BWJ607091S, BWJ607094S, BWJ607095S, BWJ607101S, BWJ607342S, BWJ607343S, BWJ607344S, BWJ606951S, BWJ606991S, BWJ606994S, BWJ607005S, BWJ607060S, BWJ607090S, BWJ607096S, BWJ607097S, BWJ607098S, BWJ607120S, BWJ607121S, BWJ607127S, BWJ607145S, BWJ607146S, BWJ607147S, BWJ607149S, BWJ607156S, BWJ607158S, BWJ607159S, BWJ607160S, BWJ607162S, BWJ607092S, BWJ607093S, BWJ607003S, BWJ607288S, BWJ607280S, BWJ607282S, BWJ607286S, BWJ607287S, BWJ606996S, BWJ606998S, BWJ607016S, BWJ607019S, BWJ607057S, BWJ607061S, BWJ607062S, BWJ607063S, BWJ607074S, BWJ607078S, BWJ607082S, BWJ607084S, BWJ607085S, BWJ607104S, BWJ607105S, BWJ607106S, BWJ607123S, BWJ607124S, BWJ607131S, BWJ607163S, BWJ607168S, BWJ607174S, BWJ607178S, BWJ607179S, BWJ607182S, BWJ607069S, BWJ607079S, BWJ607107S, BWJ607108S, BWJ607114S, BWJ607115S, BWJ607126S, BWJ607151S, BWJ607161S, BWJ607181S, BWJ607273S, BWJ607064S… Full codes in the FDA record | 447 units |
| Z-1799-2023 | ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM205000H, BWM204927H, BWM204911H, BWM204921H, BWM204926H, BWM204932H, BWM204936H, BWM204944H, BWM204954H, BWM204955H, BWM204959H, BWM204983H, BWM204984H, BWM204989H, BWM204990H, BWM205004H, BWM205006H, BWM205008H, BWM205013H, BWM205014H, BWM205015H, BWM205016H, BWM205019H, BWM205021H, BWM205023H, BWM205024H, BWM205027H, BWM205033H, BWM205036H, BWM205037H, BWM204792H, BWM204938H, BWM204961H, BWM204916H, BWM204922H, BWM204950H, BWM204957H, BWM204993H, BWM205009H, BWM204923H, BWM204924H, BWM204987H, BWM205028H, BWM204956H, BWM204953H, BWM204789H, BWM204790H, BWM204935H, BWM204905H, BWM204906H, BWM204960H, BWM204980H, BWM204991H, BWM204914H, BWM204933H, BWM204985H, BWM204997H, BWM204948H, BWM204971H, BWM204992H, BWM205007H, BWM205034H, BWM204793H, BWM204904H, BWM204910H, BWM204970H, BWM204977H, BWM204982H, BWM204928H, BWM204930H, BWM205002H, BWM205035H, BWM204967H, BWM204974H, BWM204966H, BWM204978H, BWM204946H; GTIN 00643169720480, Lot Serial Numbers: BWM606690S, BWM606723S, BWM608186S, BWM607102S, BWM606494S, BWM607083S, BWM606927S, BWM607005S, BWM607272S, BWM606644S, BWM606971S, BWM607093S… Full codes in the FDA record | 6821 units |
| Z-1800-2023 | ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL206087H, BWL205882H, BWL206049H, BWL206050H, BWL206053H, BWL206055H, BWL206059H, BWL206069H, BWL206073H, BWL206074H, BWL206078H, BWL206079H, BWL206081H, BWL206082H, BWL206083H, BWL206084H, BWL206101H, BWL206104H, BWL206110H, BWL206112H, BWL206116H, BWL206118H, BWL206120H, BWL206122H, BWL206123H, BWL206126H, BWL206127H, BWL206068H, BWL206071H, BWL206092H, BWL206093H, BWL206094H, BWL206109H, BWL206117H, BWL206119H, BWL206097H, BWL205878H, BWL206098H, BWL206063H, BWL206114H, BWL206108H, BWL206048H, BWL206064H, BWL206058H, BWL206086H, BWL206099H, BWL206076H, BWL206103H, BWL206107H, BWL206124H, BWL206125H, BWL206105H, BWL206051H, BWL206054H; GTIN 00643169720459, Lot Serial Numbers: BWL606762S, BWL606799S, BWL609508S, BWL606741S, BWL607597S, BWL607510S, BWL607234S, BWL606748S, BWL607162S, BWL607513S, BWL607947S, BWL606791S, BWL607876S, BWL606995S, BWL607071S, BWL606857S, BWL606752S, BWL607088S, BWL606806S, BWL606900S, BWL606908S, BWL606738S, BWL606758S, BWL606759S, BWL607084S, BWL607199S, BWL607220S, BWL607277S, BWL607512S, BWL607519S, BWL607558S, BWL607571S, BWL607805S, BWL607806S, BWL609503S… Full codes in the FDA record | 5296 units |
| Z-1801-2023 | ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators; GTIN 00763000115647, Lot Serial Numbers: EVR600484S, EVR600487S, EVR600488S, EVR600489S, EVR600490S, EVR600492S, EVR600494S, EVR600479S, EVR600480S, EVR600483S, EVR600500S, EVR600495S, EVR600496S, EVR600478S, EVR600516S, EVR600517S, EVR600519S, EVR600521S, EVR600522S, EVR600525S, EVR600526S | 21 units |
| Z-1802-2023 | ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators; GTIN 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S… Full codes in the FDA record | 289 units |
| Z-1803-2023 | ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators; GTIN 00643169837799, Lot Serial Numbers: CWG208686H, CWG211264H, CWG205930H, CWG208117H, CWG210956H, CWG210958H, CWG211814H, CWG212178H, CWG208135H, CWG209489H, CWG209599H, CWG212702H, CWG214349H, CWG214379H, CWG206584H, CWG208347H, CWG206776H, CWG206895H, CWG211478H, CWG211709H, CWG212079H, CWG212183H, CWG212836H, CWG205283H, CWG205284H, CWG205288H, CWG207805H, CWG207808H, CWG207809H, CWG207810H, CWG207811H, CWG207812H, CWG208949H, CWG209030H, CWG209031H, CWG209285H, CWG209646H, CWG209659H, CWG209823H, CWG210928H, CWG210929H, CWG211866H, CWG212840H, CWG212841H, CWG212842H, CWG212843H, CWG212844H, CWG212846H, CWG212847H, CWG212851H, CWG212853H, CWG212854H, CWG213620H, CWG213622H, CWG213623H, CWG206242H, CWG206868H, CWG209799H, CWG212914H, CWG205298H, CWG205299H, CWG205450H, CWG205777H, CWG206838H, CWG206972H, CWG208335H, CWG208502H, CWG209280H, CWG209978H, CWG209979H, CWG209981H, CWG209982H, CWG209983H, CWG211070H, CWG211071H, CWG211072H, CWG211696H, CWG212566H, CWG212568H, CWG212569H, CWG213285H, CWG213505H, CWG213756H, CWG214277H, CWG214324H, CWG204936H, CWG205368H, CWG206168H, CWG208188H, CWG208467H, CWG213778H, CWG206589H, CWG206593H, CWG209988H, CWG210659H, CWG213726H, CWG213727H, CWG213728H, CWG208549H… Full codes in the FDA record | 12099 units |
| Z-1804-2023 | ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H, PKX234197H, PKX234214H, PKX234215H, PKX234216H, PKX234217H, PKX234220H, PKX234221H, PKX236947H, PKX237017H, PKX237021H, PKX237022H, PKX237023H, PKX237024H, PKX237037H, PKX237040H, PKX237043H, PKX237044H, PKX237045H, PKX237046H… Full codes in the FDA record | 34350 units |
| Z-1805-2023 | ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S… Full codes in the FDA record | 4546 units |
| Z-1806-2023 | ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169717992, Lot Serial Numbers: PLX607314S, PLX608121S, PLX612778S, PLX613087S, PLX604547S, PLX610926S, PLX606361S, PLX608125S, PLX610724S, PLX610983S, PLX609285S, PLX608127S, PLX608938S, PLX610866S, PLX612123S, PLX608086S, PLX608118S, PLX609410S, PLX610864S, PLX610961S, PLX610967S, PLX611934S, PLX611951S, PLX614024S, PLX614073S, PLX608054S, PLX605322S, PLX614114S, PLX607228S, PLX607330S, PLX607943S, PLX613085S, PLX609803S, PLX607928S, PLX605323S, PLX607310S, PLX607333S, PLX606750S, PLX608915S, PLX608983S, PLX609494S, PLX610736S, PLX610740S, PLX610953S, PLX610949S, PLX612097S, PLX608914S, PLX607332S, PLX607785S, PLX607788S, PLX609693S, PLX609858S, PLX608510S, PLX607200S, PLX610731S, PLX606698S, PLX607506S, PLX610276S, PLX606134S, PLX605235S, PLX606368S, PLX612749S, PLX607386S, PLX606748S, PLX610920S, PLX614233S, PLX607508S, PLX612649S, PLX612650S, PLX608980S, PLX609862S, PLX604556S, PLX610980S, PLX607566S, PLX608469S, PLX610900S, PLX606141S, PLX608096S, PLX608113S, PLX609491S, PLX609859S, PLX611893S, PLX611897S, PLX608092S, PLX607939S, PLX608401S, PLX608994S, PLX606341S, PLX609486S, PLX608954S, PLX604652S, PLX605335S, PLX605336S, PLX606958S, PLX610935S, PLX612860S, PLX609834S, PLX607784S, PLX607327S… Full codes in the FDA record | 15381 units |
| Z-1807-2023 | ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169837812, Lot Serial numbers: CWJ604194S, CWJ604707S, CWJ604057S, CWJ602128S, CWJ604288S, CWJ602870S, CWJ601914S, CWJ603587S, CWJ603802S, CWJ601000S, CWJ601001S, CWJ601158S, CWJ601706S, CWJ601799S, CWJ601845S, CWJ604343S, CWJ604387S, CWJ601910S, CWJ603379S, CWJ603449S, CWJ603454S, CWJ603109S, CWJ603385S, CWJ603717S, CWJ604036S, CWJ604043S, CWJ604092S, CWJ604118S, CWJ604397S, CWJ603165S, CWJ603501S, CWJ603684S, CWJ603685S, CWJ603693S, CWJ603831S, CWJ604218S, CWJ604314S, CWJ604338S, CWJ601875S, CWJ601903S, CWJ603686S, CWJ603836S, CWJ603869S, CWJ603875S, CWJ604377S, CWJ601894S, CWJ601905S, CWJ601909S, CWJ603429S, CWJ603660S, CWJ603060S, CWJ603731S, CWJ603760S, CWJ604336S, CWJ604355S, CWJ603859S, CWJ603697S, CWJ603700S, CWJ603849S, CWJ604337S, CWJ603687S, CWJ603695S, CWJ601906S, CWJ603445S, CWJ603873S, CWJ604179S, CWJ603842S, CWJ604042S, CWJ604094S, CWJ604339S, CWJ604358S, CWJ604117S, CWJ601891S, CWJ602956S, CWJ603275S, CWJ604684S, CWJ603881S, CWJ603884S, CWJ603939S, CWJ603957S, CWJ604167S, CWJ604178S, CWJ600977S, CWJ601408S, CWJ601788S, CWJ602434S, CWJ602745S, CWJ602880S, CWJ603241S, CWJ603297S, CWJ604580S, CWJ602700S, CWJ603061S, CWJ603107S, CWJ600881S, CWJ601208S, CWJ601611S, CWJ602039S… Full codes in the FDA record | 5622 units |
| Z-1808-2023 | ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720817. Lot Serial Numbers: PMX613090S, PMX610759S, PMX613168S, PMX604899S, PMX606600S, PMX605030S, PMX605294S, PMX605321S, PMX605409S, PMX605434S, PMX605494S, PMX605615S, PMX605865S, PMX605971S, PMX606147S, PMX606694S, PMX606698S, PMX606701S, PMX606703S, PMX606705S, PMX606859S, PMX607270S, PMX608318S, PMX611103S, PMX613896S, PMX613927S, PMX613944S, PMX612024S, PMX613712S, PMX613935S, PMX613953S, PMX611975S, PMX613088S, PMX613697S, PMX613929S, PMX613942S, PMX607559S, PMX611696S, PMX611976S, PMX611873S, PMX607595S, PMX611948S, PMX607298S, PMX611887S, PMX612112S, PMX607539S, PMX607632S, PMX611052S, PMX612018S, PMX612108S, PMX613774S, PMX613790S, PMX607549S, PMX607599S, PMX612009S, PMX612016S, PMX612119S, PMX613709S, PMX613954S, PMX609256S, PMX607521S, PMX607529S, PMX607532S, PMX607737S, PMX607742S, PMX611286S, PMX611299S, PMX611303S, PMX611687S, PMX611688S, PMX611987S, PMX612005S, PMX612008S, PMX612019S, PMX612114S, PMX612118S, PMX613076S, PMX613077S, PMX613081S, PMX613312S, PMX613324S, PMX613437S, PMX613536S, PMX613539S, PMX613558S, PMX613561S, PMX613695S, PMX613702S, PMX613708S, PMX613711S, PMX613931S, PMX614118S, PMX614120S, PMX607517S, PMX607520S, PMX607545S, PMX607700S, PMX613443S, PMX613446S… Full codes in the FDA record | 16244 units |
| Z-1809-2023 | ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators; GTIN 00643169720558, Lot Serial Numbers: PKZ212063H, PKZ212047H, PKZ212048H, PKZ212049H, PKZ212050H, PKZ212055H, PKZ212061H, PKZ212062H, PKZ212042H, PKZ212039H, PKZ212041H, PKZ212027H, PKZ212032H, PKZ212033H, PKZ212035H, PKZ212044H, PKZ212053H, PKZ212054H, PKZ212056H, PKZ212057H | 20 units |
| Z-1810-2023 | ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators; GTIN 00643169837768, Lot Serial Numbers: CWE602084S, CWE601758S, CWE600712S, CWE602003S, CWE600626S, CWE600766S, CWE601482S, CWE601602S, CWE602520S, CWE602570S, CWE602622S, CWE601590S, CWE602288S, CWE601918S, CWE602150S, CWE602184S, CWE602565S, CWE602589S, CWE600926S, CWE600588S, CWE601390S, CWE601395S, CWE601481S, CWE601541S, CWE601612S, CWE601749S, CWE601831S, CWE601843S, CWE602038S, CWE600874S, CWE601632S, CWE601996S, CWE602041S, CWE601792S, CWE602396S, CWE600375S, CWE601990S, CWE600553S, CWE601369S, CWE601392S, CWE601766S, CWE601769S, CWE601695S, CWE601401S, CWE601470S, CWE602016S, CWE602094S, CWE602195S, CWE602495S, CWE600746S, CWE601256S, CWE600733S, CWE601348S, CWE601487S, CWE601524S, CWE600350S, CWE600974S, CWE601438S, CWE601700S, CWE601989S, CWE602012S, CWE602376S, CWE600461S, CWE600373S, CWE600530S, CWE601325S, CWE601582S, CWE601644S, CWE601701S, CWE601995S, CWE601282S, CWE601850S, CWE601890S, CWE600526S, CWE602605S, CWE600525S, CWE600372S, CWE600396S, CWE601006S, CWE601277S, CWE601694S, CWE601596S, CWE601652S, CWE601992S, CWE602044S, CWE601462S, CWE601538S, CWE600725S, CWE600729S, CWE601579S, CWE602053S, CWE601643S, CWE602123S, CWE601993S, CWE600935S, CWE600936S, CWE601442S, CWE601444S, CWE601533S… Full codes in the FDA record | 2310 units |
| Z-1811-2023 | ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators; GTIN 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S, PLZ613227S, PLZ613228S, PLZ610496S, PLZ611729S, PLZ613235S, PLZ613279S, PLZ613296S, PLZ610318S, PLZ610326S, PLZ610352S, PLZ610458S, PLZ610459S, PLZ611004S, PLZ611730S, PLZ611922S, PLZ612232S, PLZ612654S, PLZ612815S, PLZ613229S… Full codes in the FDA record | 6477 units |
| Z-1812-2023 | ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators; GTIN 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S, CWF601666S, CWF602110S, CWF601293S, CWF601557S, CWF601667S, CWF601782S, CWF602154S, CWF601290S, CWF601563S, CWF605395S, CWF601668S, CWF601669S, CWF601675S, CWF606033S, CWF602902S, CWF601471S, CWF602974S, CWF603047S, CWF602754S… Full codes in the FDA record | 6525 units |
| Z-1813-2023 | ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators; GTIN 00643169720596, Lot Serial Numbers: PMZ618802S, PMZ616324S, PMZ616325S, PMZ618783S, PMZ614007S, PMZ616319S, PMZ616311S, PMZ616317S, PMZ616329S, PMZ614015S, PMZ614036S, PMZ616320S, PMZ613982S, PMZ615518S, PMZ616318S, PMZ616327S, PMZ618780S, PMZ618807S, PMZ618813S, PMZ616312S, PMZ616323S, PMZ618796S, PMZ619084S, PMZ618785S, PMZ616326S, PMZ618798S, PMZ614044S, PMZ612017S, PMZ612853S, PMZ613328S, PMZ613097S, PMZ614065S, PMZ614046S, PMZ613063S, PMZ613316S, PMZ614003S, PMZ614010S, PMZ614033S, PMZ614097S, PMZ613087S, PMZ613201S, PMZ614058S, PMZ614099S, PMZ613212S, PMZ613219S, PMZ613207S, PMZ613206S, PMZ613318S, PMZ613962S, PMZ614002S, PMZ613216S, PMZ613313S, PMZ613073S, PMZ613077S, PMZ613079S, PMZ613082S, PMZ613998S, PMZ613999S, PMZ614000S, PMZ614083S, PMZ614085S, PMZ614087S, PMZ614092S, PMZ614093S, PMZ613078S, PMZ614042S, PMZ613189S, PMZ613098S, PMZ613071S, PMZ613891S, PMZ613892S, PMZ613893S, PMZ613894S, PMZ613895S, PMZ614024S, PMZ614026S, PMZ614027S, PMZ614028S, PMZ614029S, PMZ614060S, PMZ614094S, PMZ615795S, PMZ614012S, PMZ614014S, PMZ614034S, PMZ613069S, PMZ614021S, PMZ614025S, PMZ614055S, PMZ613881S, PMZ614030S, PMZ614095S, PMZ613976S, PMZ613977S, PMZ614062S, PMZ614071S, PMZ613322S, PMZ613033S, PMZ613034S… Full codes in the FDA record | 25058 |
| Z-1814-2023 | ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators; GTIN 00763000001520, Lot Serial Numbers: CWK604305S, CWK601554S, CWK601693S, CWK601762S, CWK603310S, CWK600674S, CWK605298S, CWK605119S, CWK605216S, CWK605052S, CWK605244S, CWK605024S, CWK605176S, CWK605108S, CWK605326S, CWK605015S, CWK605215S, CWK605100S, CWK605123S, CWK604958S, CWK605229S, CWK605502S, CWK604624S, CWK604625S, CWK604396S, CWK605478S, CWK604413S, CWK604933S, CWK605391S, CWK601948S, CWK601949S, CWK601950S, CWK601953S, CWK601961S, CWK601965S, CWK601966S, CWK601970S, CWK601971S, CWK601972S, CWK601974S, CWK601976S, CWK602568S, CWK602617S, CWK602627S, CWK602632S, CWK602691S, CWK602827S, CWK602843S, CWK602870S, CWK601348S, CWK603369S, CWK604247S, CWK604852S, CWK603773S, CWK601726S, CWK601802S, CWK602031S, CWK602325S, CWK602330S, CWK602332S, CWK602336S, CWK602338S, CWK602339S, CWK602355S, CWK602357S, CWK602577S, CWK602645S, CWK602652S, CWK603257S, CWK603258S, CWK603319S, CWK603334S, CWK603926S, CWK603957S, CWK603969S, CWK604118S, CWK604120S, CWK604127S, CWK604307S, CWK604310S, CWK604313S, CWK604321S, CWK605197S, CWK605198S, CWK605207S, CWK605208S, CWK605209S, CWK605210S, CWK605211S, CWK605212S, CWK605449S, CWK605470S, CWK605473S, CWK603235S, CWK603237S, CWK603242S, CWK601913S, CWK602871S, CWK603546S, CWK604544S… Full codes in the FDA record | 5215 units |
| Z-1815-2023 | ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators; GTIN 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL606893S, CWL611845S, CWL613316S, CWL613041S, CWL613322S, CWL613037S, CWL612708S, CWL610673S, CWL613504S, CWL613431S, CWL610444S, CWL611258S, CWL612781S, CWL611134S, CWL612934S, CWL610677S, CWL610760S, CWL611725S, CWL612705S, CWL612392S, CWL612791S, CWL613155S, CWL608262S, CWL613137S, CWL613177S, CWL613296S, CWL613214S, CWL613134S, CWL610869S, CWL612023S, CWL605532S, CWL604332S, CWL604336S, CWL604346S, CWL604350S, CWL604352S, CWL604353S, CWL604357S, CWL604361S, CWL604363S, CWL604365S, CWL604367S, CWL604368S, CWL605564S, CWL605583S, CWL605779S, CWL607583S, CWL607825S, CWL608913S, CWL608914S, CWL608966S, CWL609174S, CWL601407S, CWL602224S, CWL604372S, CWL604374S, CWL607414S, CWL607688S, CWL609146S, CWL609294S, CWL610670S, CWL604082S, CWL604249S, CWL604273S, CWL604611S, CWL605101S, CWL605102S, CWL605103S, CWL605105S, CWL605106S, CWL605233S, CWL605235S, CWL605632S, CWL605645S, CWL605652S, CWL606263S, CWL606411S, CWL606795S, CWL607038S, CWL607089S, CWL607337S, CWL607340S, CWL607415S, CWL607803S, CWL608025S, CWL608038S, CWL608141S, CWL608274S, CWL609467S, CWL609469S, CWL609499S, CWL609898S, CWL609902S, CWL609905S… Full codes in the FDA record | 14270 units |
| Z-1816-2023 | ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators; GTIN 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP602486S, CWP601838S, CWP600696S, CWP602627S, CWP602315S, CWP602621S, CWP604004S, CWP603407S, CWP603894S, CWP604066S, CWP602233S, CWP603772S, CWP603201S, CWP603888S, CWP602797S, CWP603582S, CWP603254S, CWP603475S, CWP602907S, CWP603605S, CWP603606S, CWP602148S, CWP602999S, CWP601940S, CWP602860S, CWP600692S, CWP600693S, CWP601684S, CWP601750S, CWP602026S, CWP602250S, CWP602395S, CWP600661S, CWP600672S, CWP600673S, CWP601025S, CWP601261S, CWP601303S, CWP601404S, CWP601545S, CWP601730S, CWP601740S, CWP601753S, CWP601912S, CWP602158S, CWP602213S, CWP602504S, CWP602670S, CWP603190S, CWP603321S, CWP603588S, CWP601814S, CWP603269S, CWP600319S, CWP600528S, CWP600165S, CWP600198S, CWP600259S, CWP600347S, CWP600382S, CWP600924S, CWP601414S, CWP601449S, CWP601852S, CWP602821S, CWP602897S, CWP602949S, CWP602991S, CWP604050S, CWP601592S, CWP600897S, CWP602865S, CWP600265S, CWP600261S, CWP602153S, CWP600326S, CWP600355S, CWP600697S, CWP600738S, CWP602332S, CWP603593S, CWP600566S, CWP601527S, CWP601561S, CWP600205S, CWP601559S, CWP602115S, CWP600948S, CWP602089S, CWP602090S, CWP602259S, CWP600701S, CWP600954S, CWP601021S… Full codes in the FDA record | 3852 units |
| Z-1817-2023 | ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators; GTIN 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S, CWR605233S, CWR605740S, CWR606077S, CWR606621S, CWR607419S, CWR607905S, CWR609837S, CWR609987S, CWR610588S, CWR611070S, CWR611189S, CWR611604S, CWR611683S, CWR613086S, CWR614108S, CWR614126S, CWR614582S, CWR600290S, CWR600798S, CWR600903S… Full codes in the FDA record | 14989 units |
| Z-1818-2023 | ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators; GTIN 00763000178451, Lot Serial Numbers: RSC601940S, RSC601072S, RSC601241S, RSC600327S, RSC601396S, RSC602028S, RSC602030S, RSC602031S, RSC602036S, RSC600018S, RSC602529S, RSC602530S, RSC602531S, RSC602532S, RSC600347S, RSC600391S, RSC600419S, RSC601490S, RSC602703S, RSC600337S, RSC600420S, RSC600421S, RSC600422S, RSC600423S, RSC600501S, RSC601410S, RSC601433S, RSC602269S, RSC601444S, RSC601446S, RSC602764S, RSC602765S, RSC600131S, RSC600281S, RSC600298S, RSC601388S, RSC602497S, RSC600174S, RSC602387S, RSC601415S, RSC602106S, RSC600225S, RSC600240S, RSC601647S, RSC602710S, RSC601960S, RSC601961S, RSC602209S, RSC602257S, RSC602306S, RSC602379S, RSC602473S, RSC600293S, RSC600299S, RSC600328S, RSC601071S, RSC601345S, RSC601443S, RSC601450S, RSC601632S, RSC601887S, RSC602213S, RSC602144S, RSC602234S, RSC601419S, RSC602168S, RSC600147S, RSC600417S, RSC601631S, RSC600275S, RSC601999S, RSC602394S, RSC602701S, RSC602752S, RSC602620S, RSC600443S, RSC602061S, RSC602064S, RSC602068S, RSC602072S, RSC602073S, RSC602075S, RSC602076S, RSC602433S, RSC601216S, RSC601221S, RSC601222S, RSC601223S, RSC601227S, RSC601228S, RSC601229S, RSC601230S, RSC601231S, RSC601532S, RSC601534S, RSC601537S, RSC601538S, RSC601541S, RSC601543S… Full codes in the FDA record | 2000 units |
| Z-1819-2023 | ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators; GTIN 00763000178468. Lot Serial numbers: RSD605765S, RSD605767S, RSD607880S, RSD607881S, RSD607886S, RSD607890S, RSD603551S, RSD603552S, RSD603553S, RSD603554S, RSD603555S, RSD600536S, RSD601541S, RSD602283S, RSD602524S, RSD602542S, RSD602924S, RSD603303S, RSD603396S, RSD607136S, RSD608177S, RSD608547S, RSD606272S, RSD607000S, RSD607711S, RSD607712S, RSD602036S, RSD602645S, RSD602659S, RSD603096S, RSD603670S, RSD604815S, RSD608193S, RSD605918S, RSD605919S, RSD605920S, RSD605921S, RSD605922S, RSD605923S, RSD605924S, RSD605926S, RSD605927S, RSD605929S, RSD605930S, RSD605931S, RSD605932S, RSD605933S, RSD604238S, RSD604294S, RSD604312S, RSD604313S, RSD604314S, RSD604614S, RSD604616S, RSD604710S, RSD604721S, RSD604725S, RSD605925S, RSD607788S, RSD607789S, RSD607790S, RSD607791S, RSD607792S, RSD607793S, RSD607794S, RSD607795S, RSD607797S, RSD607800S, RSD607801S, RSD607802S, RSD609083S, RSD609084S, RSD609085S, RSD605068S, RSD608525S, RSD609065S, RSD609066S, RSD609067S, RSD609069S, RSD609071S, RSD609072S, RSD609073S, RSD609075S, RSD609079S, RSD609080S, RSD609081S, RSD609082S, RSD601603S, RSD601960S, RSD602778S, RSD603181S, RSD603321S, RSD603672S, RSD603879S, RSD606554S, RSD608293S, RSD600145S, RSD601926S, RSD602728S, RSD603152S… Full codes in the FDA record | 9325 units |
| Z-1820-2023 | ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators; GTIN 00763000178499, Lot Serial Numbers: RSE600116S, RSE600346S, RSE600428S, RSE600572S, RSE600505S, RSE600512S, RSE600513S, RSE600515S, RSE600517S, RSE600518S, RSE600519S, RSE600520S, RSE601603S, RSE601609S, RSE601846S, RSE601849S, RSE601856S, RSE601872S, RSE601873S, RSE602612S, RSE600806S, RSE601469S, RSE600412S, RSE600554S, RSE602156S, RSE602245S, RSE602658S, RSE601353S, RSE600764S, RSE602060S, RSE600993S, RSE602062S, RSE602445S, RSE600734S, RSE601371S, RSE602291S, RSE602297S, RSE600746S, RSE601898S, RSE602099S, RSE600431S, RSE600674S, RSE601618S, RSE601619S, RSE601620S, RSE601621S, RSE601622S, RSE600190S, RSE600193S, RSE601209S, RSE601330S, RSE601355S, RSE601504S, RSE600672S, RSE602161S, RSE601259S, RSE602483S, RSE602484S, RSE600831S, RSE601521S, RSE602381S, RSE600466S, RSE602661S, RSE601694S, RSE602144S, RSE601665S, RSE600452S, RSE601575S, RSE602255S, RSE600158S, RSE601717S, RSE601721S, RSE601724S, RSE600285S, RSE601560S, RSE601774S, RSE601962S, RSE602295S, RSE600579S, RSE602177S, RSE600272S, RSE602293S, RSE602416S, RSE602070S, RSE602117S, RSE602173S, RSE602183S, RSE602314S, RSE602597S, RSE600621S, RSE602513S, RSE600290S, RSE600424S, RSE600681S, RSE602573S, RSE600323S, RSE600675S, RSE601667S, RSE602071S, RSE601954S… Full codes in the FDA record | 1930 units |
| Z-1821-2023 | ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators; GTIN 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF602653S, RSF603908S, RSF601102S, RSF607914S, RSF605967S, RSF600633S, RSF600649S, RSF600867S, RSF600868S, RSF600869S, RSF600872S, RSF600873S, RSF600874S, RSF600875S, RSF600876S, RSF600878S, RSF600880S, RSF600883S, RSF602930S, RSF602991S, RSF602998S, RSF603002S, RSF603003S, RSF603013S, RSF603018S, RSF603019S, RSF603022S, RSF603026S, RSF603027S, RSF603030S, RSF603032S, RSF603033S, RSF603034S, RSF603035S, RSF603036S, RSF603736S, RSF603737S, RSF603741S, RSF603742S, RSF603744S, RSF603746S, RSF603747S, RSF603749S, RSF603754S, RSF603755S, RSF603756S, RSF603758S, RSF603759S, RSF603762S, RSF603763S, RSF603764S, RSF603799S, RSF603802S, RSF603804S, RSF603806S, RSF603810S, RSF603813S, RSF603818S, RSF603821S, RSF603824S, RSF602665S, RSF602703S, RSF603249S, RSF603648S, RSF603939S, RSF607644S, RSF601171S, RSF601174S, RSF602584S, RSF602743S, RSF600887S, RSF602678S, RSF608130S, RSF600767S, RSF608097S, RSF604855S, RSF606263S, RSF601206S, RSF601486S, RSF601567S, RSF601571S, RSF600924S, RSF601224S, RSF601226S, RSF602817S, RSF603405S, RSF603521S, RSF603678S, RSF602595S, RSF604129S, RSF600687S, RSF600210S, RSF602849S, RSF607243S… Full codes in the FDA record | 7048 units |
| Z-1822-2023 | ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators; GTIN 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG600125S, RSG600193S, RSG600006S, RSG600016S, RSG600123S, RSG600136S, RSG600573S, RSG600113S, RSG600249S, RSG600395S, RSG600579S, RSG600173S, RSG600111S, RSG600112S, RSG600116S, RSG600118S, RSG600130S, RSG600143S, RSG600175S, RSG600191S, RSG600205S, RSG600209S, RSG600272S, RSG600564S, RSG600167S, RSG600187S, RSG600077S, RSG600131S, RSG600145S, RSG600162S, RSG600245S, RSG600253S, RSG600512S, RSG600519S, RSG600037S, RSG600536S, RSG600544S, RSG600210S, RSG600643S, RSG600642S, RSG600122S, RSG600138S, RSG600174S, RSG600200S, RSG600225S, RSG600233S, RSG600585S, RSG600134S, RSG600168S, RSG600148S, RSG600132S, RSG600240S, RSG600055S, RSG600121S, RSG600179S, RSG600186S, RSG600158S, RSG600181S, RSG600219S, RSG600108S, RSG600164S, RSG600255S, RSG600511S, RSG600109S, RSG600110S, RSG600115S, RSG600117S, RSG600178S, RSG600250S, RSG600560S, RSG600083S, RSG600581S, RSG600639S, RSG600140S, RSG600232S, RSG600126S, RSG600141S, RSG600152S, RSG600166S, RSG600183S, RSG600204S, RSG600228S, RSG600242S, RSG600243S, RSG600246S, RSG600278S, RSG600114S, RSG600190S, RSG600201S, RSG600137S, RSG600157S, RSG600172S, RSG600171S, RSG600537S… Full codes in the FDA record | 510 units |
| Z-1823-2023 | ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators; GTIN 00763000178550. Lot Serial Numbers: RSH600068S, RSH600173S, RSH600239S, RSH601126S, RSH601127S, RSH601883S, RSH601888S, RSH601444S, RSH601463S, RSH601537S, RSH601538S, RSH600064S, RSH600099S, RSH600174S, RSH600175S, RSH600228S, RSH600275S, RSH600276S, RSH600889S, RSH600903S, RSH601415S, RSH601522S, RSH601873S, RSH600071S, RSH600906S, RSH600922S, RSH601034S, RSH601041S, RSH601123S, RSH600007S, RSH600082S, RSH600110S, RSH601765S, RSH601894S, RSH600236S, RSH600264S, RSH601531S, RSH600057S, RSH600124S, RSH600181S, RSH600211S, RSH600827S, RSH600887S, RSH601024S, RSH601036S, RSH601366S, RSH600902S, RSH601519S, RSH601520S, RSH601751S, RSH601753S, RSH601754S, RSH601805S, RSH600814S, RSH601139S, RSH601355S, RSH601407S, RSH600147S, RSH600101S, RSH601443S, RSH601460S, RSH601462S, RSH601535S, RSH601536S, RSH601539S, RSH601542S, RSH600041S, RSH600045S, RSH600055S, RSH600066S, RSH600067S, RSH600086S, RSH600097S, RSH600102S, RSH600103S, RSH600108S, RSH600109S, RSH600117S, RSH600126S, RSH600130S, RSH600142S, RSH600145S, RSH600157S, RSH600188S, RSH600199S, RSH600204S, RSH600207S, RSH600222S, RSH600225S, RSH600240S, RSH600829S, RSH601023S, RSH601058S, RSH600169S, RSH600171S, RSH600172S, RSH600815S, RSH601129S, RSH600238S, RSH601431S… Full codes in the FDA record | 2031 units |
What to do — step by step
Check Device Model
Identify if your device is an ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL model with the listed serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide - Worldwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything?
If your device matches the model and serial numbers listed, you should check with Medtronic for further instructions. Otherwise, no action is needed.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1707-2023 (May 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1707-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.