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Use caution Medical device recall · FDA · Published April 16, 2024

Medtronic EVERA MRI S VR SureScan Defibrillator Recall: Manufacturing Defect Risk

Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers; contact Medtronic for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2197-2024Medical deviceMedtronic ›
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Contact the company

Recalling firmMedtronic Inc.8200 Coral Sea St Ne · Mounds View, MN 55112-4391
✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Evera MRI S VR SureScan defibrillators because a manufacturing defect may cause weld cracks that fail during quality checks. This could lead to device malfunction if the device is used. Read more at govinfonow.com/recall/55368-medtronic-evera-mri-s-vr-surescan-defibrillator-recall-manufacturing-defect.

Source Summary by GovInfoNow · govinfonow.com/recall/55368-medtronic-evera-mri-s-vr-surescan-defibrillator-recall-manufacturing-defect · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2197-2024

Cite this page

“Medtronic EVERA MRI S VR SureScan Defibrillator Recall: Manufacturing Defect Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55368-medtronic-evera-mri-s-vr-surescan-defibrillator-recall-manufacturing-defect. Based on FDA recall #Z-2197-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2197-2024%22&limit=1).

The FDA announced on April 16, 2024, that Medtronic Inc. is recalling EVERA MRI S VR SureScan Implantable Cardioverter Defibrillators due to a potential manufacturing defect involving weld cracks. The agency stated the defect could cause devices to fail during the leak check step in manufacturing.

How to tell if you have it

  • Brand: Medtronic
  • Product: EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
  • UPC: 00763000206208
  • Serial Numbers: PMZ646287S, PMZ646288S, PMZ646289S, PMZ646291S, PMZ646292S, PMZ646295S, PMZ646299S, PMZ646300S, PMZ646302S, PMZ646303S, PMZ646304S, PMZ646305S, PMZ646306S, PMZ646307S
  • Distribution: Worldwide including US states CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and countries Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom

The hazard

According to the FDA, a weld crack led to devices failing at the leak check step in manufacturing. This defect presents a potential for manufacturing defect in the recalled Implantable Cardioverter Defibrillators.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Other recent recalls include the Medtronic Sphere-9 Catheter Recall (2026-03-11), the Medtronic Abre Venous Stent Recall (2025-12-04), and the Medtronic EVX 60 Series recall (2025-10-29). Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System Recall (2025-12-15), the B. Braun Medical CESK SHANDS Jackson 20055717 recall (2026-01-29), and the Philips Allura Xper FD10F Medical System Recall (2025-12-15).

How to tell if you have this one

Check the serial number on your device. Affected units have serial numbers starting with PMZ646287S through PMZ646307S. The device model is Evera MRI S VR SureScan with manufacturer code DVMC3D4.

  • Brand
    Medtronic
  • Product
    Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
  • Category
    Medical device
FDA recall event · 23 products

All 23 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 II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-2190-2024COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator; GTIN: 00763000178192, Serial Numbers: RTK624593S, RTK624594S, RTK624595S, RTK624596S, RTK624597S, RTK624599S, RTK624601S, RTK624602S, RTK624603S, RTK624604S, RTK624606S, RTK624607S; GTIN: 00763000711207, Serial Numbers: RTK624400S, RTK624405S.14
Z-2191-2024COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator; GTIN: 00763000178147, Serial Numbers: RTH608902S, RTH608907S, RTH608911S, RTH608923S, RTH608935S, RTH608966S; GTIN: 00763000711191, Serial Numbers: RTH609509S, RTH609510S.8 units
Z-2192-2024Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator; GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S.14 units
Z-2193-2024COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator; GTIN: 00763000178109, Serial Numbers: RTD607545S, RTD607549S, RTD607551S; GTIN 00763000711177, Serial Numbers: RTD607363S, RTD607364S, RTD607367S, RTD607369S, RTD607370S, RTD607374S, RTD607404S, RTD607405S.11 units
Z-2194-2024COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator; GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S58 units
Z-2195-2024CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator; GTIN: 00763000178253, Serial Number: RTS605244S; GTIN: 00763000178277, Serial Numbers: RTS604876S, RTS604877S, RTS604879S, RTS604885S; GTIN: 00763000711245, Serial Numbers: RTS604695S, RTS604698S, RTS604700S, RTS604703S, RTS604704S, RTS604714S, RTS604716S, RTS604717S, RTS604718S, RTS604721S, RTS604722S, RTS604723S, RTS604724S, RTS604726S, RTS604727S, RTS604728S, RTS604729S, RTS604730S, RTS604731S, RTS604732S, RTS604733S.26 units
Z-2196-2024EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000740559, Serial Number: BWM614493S1 unit
Z-2197-2024EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000206208, Serial Number: PMZ646287S, PMZ646288S, PMZ646289S, PMZ646291S, PMZ646292S, PMZ646295S, PMZ646299S, PMZ646300S, PMZ646302S, PMZ646303S, PMZ646304S, PMZ646305S, PMZ646306S, PMZ646307S.14 units
Z-2198-2024EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000206192, Serial Number: CWC613698S, CWC613700S, CWC613713S, CWC613715S, CWC613717S.5 units
Z-2199-2024EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000206185, Serial Numbers: PHZ659606S, PHZ659607S, PHZ659610S, PHZ659611S, PHZ659612S, PHZ659666S, PHZ659667S, PHZ659693S, PHZ659694S, PHZ659696S, PHZ659707S, PHZ659729S, PHZ659745S, PHZ659749S, PHZ659750S, PHZ659753S, PHZ659754S, PHZ659755S, PHZ659803S, PHZ659804S, PHZ659805S, PHZ659806S, PHZ659807S, PHZ659884S, PHZ659886S, PHZ659890S, PHZ659892S, PHZ659907S, PHZ659908S, PHZ659996S, PHZ660020S; GTIN: 00763000612023, Serial Numbers: PHZ659058S, PHZ659064S, PHZ659065S, PHZ659066S, PHZ659069S, PHZ659075S, PHZ659077S, PHZ659078S; GTIN: 00763000740443, Serial Number: PHZ659565S.40 units
Z-2200-2024PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000611910, Serial Numbers: CWM605634S, CWM605635S.2 units
Z-2201-2024MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000001568, Serial Numbers: CWS604689S, CWS604691S, CWS604694S3 units
Z-2202-2024MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000611941, Serial Numbers: CWT611927S, CWT611929S, CWT611932S, CWT611933S, CWT611934S, CWT611935S, CWT611936S, CWT611937S, CWT611938S, CWT611939S, CWT611940S, CWT611941S, CWT611950S, CWT611951S, CWT612011S, CWT612012S, CWT612013S, CWT612014S, CWT612015S, CWT612016S, CWT612017S, CWT612022S, CWT612044S, CWT612045S; GTIN: 00763000740368, Serial Numbers: CWT611893S, CWT611908S.26 units
Z-2203-2024PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000611965, Serial Numbers: CWL619625S, CWL619626S, CWL619627S, CWL619631S, CWL619632S, CWL619633S, CWL619634S, CWL619635S, CWL619636S, CWL619637S, CWL619638S, CWL619639S, CWL619640S, CWL619641S, CWL619642S, CWL619645S, CWL619648S, CWL619649S, CWL619650S, CWL619652S, CWL619678S, CWL619683S, CWL619700S, CWL619733S, CWL619735S, CWL620413S, CWL620414S, CWL620415S, CWL620416S, CWL620417S, CWL620421S, CWL620422S, CWL620423S, CWL620424S, CWL620425S, CWL620426S, CWL620432S, CWL620477S, CWL620480S, CWL620483S, CWL620496S, CWL620500S, CWL620501S, CWL620502S, CWL620633S, CWL620652S.46 units
Z-2204-2024MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000611972, Serial Numbers: CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, CWP605658S.6 units
Z-2205-2024MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000611989, Serial Numbers: CWR621520S, CWR621521S, CWR621522S, CWR621523S, CWR621524S, CWR621525S, CWR621526S, CWR621527S, CWR621528S, CWR621529S, CWR621530S, CWR621531S, CWR621532S.13 units
Z-2206-2024COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000711306, Serial Numbers: RSN604373S, RSN604374S, RSN604375S, RSN604376S, RSN604378S, RSN604380S, RSN604383S, RSN604385S, RSN604386S.9
Z-2207-2024COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000178406, Serial Numbers: RSO618526S, RSO618555S, RSO618559S; GTIN: 00763000711313, Serial Numbers: RSO618395S, RSO618396S, RSO618399S, RSO618400S, RSO618401S, RSO618402S, RSO618403S, RSO618405S, RSO618408S, RSO618409S, RSO618410S, RSO618412S, RSO618415S, RSO618416S, RSO618417S, RSO618419S, RSO618420S, RSO618421S, RSO618422S, RSO618439S, RSO618440S, RSO618443S, RSO618444S, RSO618580S, RSO618581S, RSO618582S, RSO618585S, RSO618586S, RSO618587S, RSO618588S, RSO618589S, RSO618590S, RSO618593S.36 units
Z-2208-2024COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator; GTIN: 00763000178512, Serial Numbers: RSF612135S, RSF612143S; GTIN: 00763000711375, Serial Numbers: RSF612097S, RSF612098S.4 units
Z-2209-2024Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator; GTIN: 00763000178338, Serial Numbers: RSL607245S, RSL607881S, RSL607883S, RSL607884S, RSL607888S.5 units
Z-2210-2024COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator; GTIN: 00763000711344, Serial Numbers: RSC604641S, RSC604642S, RSC604643S, RSC604644S, RSC604647S, RSC604653S, RSC604654S, RSC604655S.8 units
Z-2211-2024CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator; GTIN: 00763000178543, Serial Numbers: RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S; GTIN: 00763000711382, Serial Number: RSG601428S.9 units
Z-2212-2024Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.; a. GTIN: 00763000612269, Serial Numbers: BLG628370S, BLG628372S, BLG628373S. b. GTIN: 00763000206284, Serial Number: RPO606047S. c. GTIN: 00763000206222, Serial Numbers: RPB629895S, RPB629900S, RPB629902S, RPB629906S, RPB629909S, RPB629912S. d. GTIN: 00763000206307, Serial Number: RPQ610208S. e. GTIN: 00763000206291, Serial Numbers: RPK614721S, RPK614728S. f. GTIN: 00763000206253, Serial Numbers: RPP607499S, RPP607504S, RPP607517S, RPP607518S, RPP607522S, RPP607586S. g. GTIN: 00763000206246, Serial Numbers: RPG643295S, RPG643318S; GTIN 00763000611835, Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. h. GTIN: 00763000206260, Serial Numbers: RPF648668S, RPF648672S, RPF648674S, RPF648675S, RPF648676S, RPF648677S, RPF648681S, RPF648684S, RPF648685S, RPF648686S, RPF648691S, RPF648693S, RPF648702S, RPF648758S, RPF648760S, RPF648761S, RPF648762S, RPF648763S, RPF648768S, RPF648769S, RPF648770S, RPF648771S, RPF648844S, RPF648846S, RPF648847S. i. GTIN: 00763000206147, Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. j. GTIN: 00763000612191, Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. k. GTIN: 00763000206352, Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. l. GTIN: 00763000206338, Serial Numbers: PLX622054S, PLX622056S, PLX622072S.82 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the serial number on your device, which should be one of the listed numbers starting with PMZ646287S through PMZ646307S.

  2. Contact Medtronic

    Reach out to Medtronic directly for further instructions on whether your device is affected and what to do next.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 14 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Florida, Indiana, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Texas, Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Apr 16, 202412. FDA classified it Class II: Jun 26, 202423. Published in FDA’s Enforcement Report: Jul 3, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-2197-2024 (April 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2197-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA