Use caution Medical device recall · FDA · Published December 19, 2017

Medtronic ICDs: Risk of Therapy Prevention in Heart Devices

Medtronic recalls specific implantable heart devices (ICDs) due to possible failure to prevent high and low voltage therapy. Affected models include Evera MRI XT DR ICD DF1 and others with listed product numbers and serials.

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

🇺🇸 FDA recall #Z-0585-2018Medical device Medtronic ›

Use caution until it’s fixed

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Take action

Contact the company

Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain implantable heart devices (ICDs) that may not properly prevent high or low voltage therapy. This could lead to ineffective treatment of heart rhythm issues. Affected devices include specific Evera MRI models with listed product numbers and serials. Read more at govinfonow.com/recall/72274-medtronic-icds-risk-of-therapy-prevention-in-heart-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/72274-medtronic-icds-risk-of-therapy-prevention-in-heart-devices · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0585-2018

Cite this page

“Medtronic ICDs: Risk of Therapy Prevention in Heart Devices.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72274-medtronic-icds-risk-of-therapy-prevention-in-heart-devices. Based on FDA recall #Z-0585-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0585-2018%22&limit=1).

The FDA announced on 2017-12-19 that Medtronic Inc. is recalling Implantable Cardioverter Defibrillators (ICDs), Evera MRI, due to the possible prevention of high and low voltage therapy. The agency issued recall number Z-0585-2018 for the voluntary Class I action.

How to tell if you have it

Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)
Evera MRI XT DR ICD DF4 (Product No. DDMB1D4)
Evera MRI XT VR ICD DF4 (Product No. DVMB1D4)
Evera MRI S DR ICD DF1 (Product No. DDMC3D1)
Evera MRI S DR ICD DF4 (Product No. DDMC3D4)

The hazard

The recall addresses the possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). The devices automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

Context

GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 29 other recalls on record since 2018-06-06. Other recent recalls of similar products include Medtronic ICDs with glassed feedthrough risk of reduced energy output during high voltage therapy (2023-05-10), Crome Implantable Defibrillators: Reduced Shock Energy During High-Voltage Therapy (2022-06-22), and Medtronic C304-HIS Device Recall: Sterility Risk in Certain Lots (2022-04-20). Additional recent recalls include Medtronic Sphere-9 Catheter Recall: Risk of Ventricular Fibrillation with Biotronik ICDs (2026-03-11), Medtronic DLP Retrograde Cannula Recall: Sterile Barrier Breach Risk (2026-04-21), and Medtronic DLP Cannula Recall: Sterile Barrier Breach Risk (2026-04-21).

How to tell if you have this one

Check if your device is labeled as Evera MRI XT DR ICD DF1, DF4, VR ICD DF4, or S DR ICD DF1. Look for the product numbers (DDMB1D1, DDMB1D4, DVMB1D4, DDMC3D1) and serial numbers listed in the recall notice.

Brand
Medtronic
Category
Medical device

FDA recall event · 8 products

All 8 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
Terminated
Distribution
US Nationwide Distribution.

Recall number	Product, codes & lots
Z-0582-2018	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DTMB1D4: UDI 00643169543430 (Serial No. RPJ201956H, RPJ202805H) (EXPANSION: Serial No. RPJ201660H, RPJ201661H, RPJ201972H, RPJ202145H, RPJ202821H, RPJ203208H, RPJ203209H, RPJ203826H); b. Product No. DTMB1Q1: UDI 00643169705784 (Serial No. RPU201108H) (EXPANSION: Serial No. RPU201289H, RPU201290H, RPU201291H, RPU201292H, RPU201293H, RPU201295H, RPU201296H, RPU201297H, RPU201298H, RPU201299H, RPU201300H, RPU201301H, RPU201302H, RPU201303H, RPU201305H, RPU201306H, RPU201287H, RPU201288H, RPU201619H, RPU201621H, RPU201635H, RPU201304H); c. Product No. DTMB1QQ: UDI 00643169929647 (Serial No. RPE219331H, RPE218183H), 00643169543386 (Serial No. RPE201417H, RPE204789H, RPE206207H, RPE207850H, RPE209095H, RPE212027H) (EXPANSION: Serial No. RPE215624H, RPE217014H, RPE200352H, RPE200394H, RPE201115H, RPE201328H, RPE202133H, RPE202941H, RPE203460H, RPE203771H, RPE203998H, RPE204209H, RPE204790H, RPE204791H, RPE204792H, RPE205432H, RPE206879H, RPE206886H, RPE208041H, RPE208241H, RPE208355H, RPE208369H, RPE208613H, RPE209037H, RPE209093H, RPE209135H, RPE209190H, RPE209194H, RPE209553H, RPE210227H, RPE210228H, RPE210672H, RPE210673H, RPE210734H, RPE210841H, RPE210844H, RPE210869H, RPE210870H, RPE210874H, RPE210875H, RPE211011H, RPE211012H, RPE211731H, RPE211732H, RPE211734H, RPE211736H, RPE211820H, RPE211858H, RPE211859H, RPE213564H, RPE214135H, RPE214544H, RPE214545H, RPE214546H, RPE215260H, RPE215628H, RPE216247H, RPE217013H, RPE217332H, RPE217335H, RPE217399H, RPE217443H, RPE217444H, RPE217446H, RPE217850H, RPE218146H, RPE218307H, RPE218308H, RPE219117H, RPE210877H, RPE215451H, RPE215625H, RPE215627H, RPE217445H, RPE217849H, RPE218148H, RPE215626H); EXPANSION: d. Product No. DTMB1D1: UDI 00643169705791 (Serial No. RPV200926H, RPV201075H, RPV201757H, RPV201758H)
Z-0583-2018	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H); b. Product No. DTMC1QQ: UDI 00643169565272 (Serial No. RPL201034H) (EXPANSION: Serial No. RPL200052H, RPL200534H, RPL201039H, RPL201059H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPL201234H)
Z-0584-2018	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DTBB1QQ: UDI 00643169530218 (Serial No. BLK204122H) (EXPANSION: Serial No. BLK202087H, BLK203257H, BLK204050H, BLK204435H); b. Product No. DTBA1QQ: UDI 00643169007222 (Serial No. BLC224272H) (EXPANSION: Serial No. BLC200490H, BLC205825H, BLC205826H, BLC205827H, BLC206202H, BLC206263H, BLC208305H, BLC208471H, BLC211869H, BLC215219H, BLC215544H, BLC218906H, BLC219515H, BLC220190H, BLC221044H, BLC221045H, BLC221046H, BLC221047H, BLC222903H, BLC223278H, BLC223517H, BLC224374H, BLC224553H, BLC224554H, BLC224555H, BLC224556H, BLC224655H, BLC225498H, BLC225502H, BLC225682H, BLC225734H, BLC226030H, BLC226031H, BLC226032H, BLC226033H, BLC226034H, BLC226035H, BLC226040H, BLC227270H, BLC227659H, BLC227662H, BLC205767H, BLC205828H, BLC211870H, BLC226988H, BLC227212H, BLC227728H, BLC227740H), 00643169530171 (Serial No. BLC227175H, BLC227641H); c. Product No. DTBB1D1: UDI 00643169007185 (Serial No. BLO204984H) EXPANSION: Serial No. BLO210650H, BLO212502H, BLO201695H, BLO204429H, BLO206930H, BLO207702H, BLO208974H, BLO210408H, BLO210409H, BLO210770H, BLO212131H, BLO212481H, BLO212491H, BLO212493H, BLO212503H, BLO212504H, BLO212505H, BLO212506H, BLO212507H, BLO212729H, BLO213454H, BLO213467H, BLO213468H, BLO213592H, BLO213780H, BLO213781H, BLO201347H, BLO201436H, BLO208063H, BLO212501H, BLO213783H, BLO213784H, BLO213786H); d. Product No. DTBA1D1: UDI 00643169530140 (Serial No. BLF253790H, BLF254092H, BLF250740H, BLF251155H), 00643169007246 (Serial No. BLF216780H, BLF231229H) (EXPANSION: Serial No. BLF243217H, BLF247858H, BLF202387H, BLF202535H, BLF204112H, BLF205853H, BLF206730H, BLF206788H, BLF207518H, BLF207678H, BLF210779H, BLF210782H, BLF211003H, BLF211357H, BLF211358H, BLF213450H, BLF213658H, BLF218473H, BLF219583H, BLF219667H, BLF221248H, BLF222061H, BLF224098H, BLF224106H, BLF224214H, BLF224230H, BLF224242H, BLF224253H, BLF224260H, BLF224386H, BLF224483H, BLF227680H, BLF227903H, BLF227947H, BLF228849H, BLF230968H, BLF232235H, BLF232254H, BLF234692H, BLF235138H, BLF237753H, BLF238241H, BLF238700H, BLF239221H, BLF239916H, BLF243268H, BLF243674H, BLF245571H, BLF245572H, BLF245893H, BLF246563H, BLF247381H, BLF247435H, BLF247466H, BLF248396H, BLF248398H, BLF248399H, BLF248400H, BLF248401H, BLF248402H, BLF248403H, BLF248464H, BLF249952H, BLF250022H, BLF250142H, BLF250143H, BLF250389H, BLF250392H, BLF250393H, BLF250751H, BLF251380H, BLF253085H, BLF253406H, BLF253407H, BLF253618H, BLF253795H, BLF253796H, BLF253798H, BLF253801H, BLF253802H, BLF253803H, BLF253806H, BLF253820H, BLF253853H, BLF254774H, BLF254776H, BLF254777H, BLF254778H, BLF254779H, BLF200834H, BLF205341H, BLF218472H, BLF218474H, BLF220892H, BLF224264H, BLF250752H, BLF205821H, BLF210550H, BLF222642H, BLF251852H, BLF253755H, BLF253852H, BLF253797H, BLF253799H), 00643169929296 (Serial No. BLF255165H, BLF255598H; e. Product No. DTBA1D4: UDI 00643169530157 (Serial No. BLE219903H), 00643169929302 (Serial No. BLE220200H), EXPANSION: UDI 00643169007239 (Serial No. BLE205339H, BLE203253H, BLE203582H, BLE203583H, BLE204049H, BLE205304H, BLE209377H, BLE209554H, BLE212368H, BLE213926H, BLE218673H, BLE218892H, BLE218902H, BLE219909H, BLE219911H, BLE219914H, BLE208468H, BLE204048H, BLE214123H, BLE217805H, BLE219910H, BLE220390H, BLE219912H); EXPANSION: f. Product No. DTBB1Q1: UDI 00643169017993 (Serial No. BLM201868H, BLM202644H, BLM202773H, BLM202775H); g. Product No. DTBA1Q1: UDI 00643169018013 (Serial No, BLD202507H, BLD202778H, BLD203541H, BLD207024H, BLD208443H, BLD209856H, BLD210102H, BLD210103H, BLD210175H, BLD210220H, BLD210223H, BLD210251H, BLD210257H, BLD210258H, BLD210259H, BLD210260H, BLD211370H, BLD211371H, BLD211681H, BLD211682H, BLD202666H, BLD210700H, BLD210738H, BLD211680H, BLD210699H); h. Product No. DTBB1D4: UDI 00643169007178 (Serial No. BLN201692H, BLN201722H, BLN202203H, BLN202897H, BLN204159H, BLN202355H)
Z-0585-2018	Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DDMB1D1: UDI 00643169929197 (Serial No. CWA207109H) (EXPANSION Serial No. CWA207132H, CWA200074H, CWA200576H, CWA200619H, CWA200837H, CWA200888H, CWA201175H, CWA201443H, CWA201760H, CWA201771H, CWA203003H, CWA203389H, CWA204111H, CWA204889H, CWA204890H, CWA205625H, CWA205694H, CWA205695H, CWA205703H, CWA206083H, CWA206177H, CWA206178H, CWA206179H, CWA206180H, CWA206330H, CWA206666H, CWA206667H, CWA206779H, CWA206780H, CWA207122H, CWA207123H, CWA207125H, CWA207126H, CWA207128H, CWA207131H, CWA207218H, CWA207220H, CWA206176H, CWA205686H, CWA205697H, CWA206175H, CWA206785H, CWA207120H), 00643169717282 (Serial No. CWA200012H, CWA202259H, CWA203498H); b. Product No. DDMB1D4: UDI 00643169929203 (Serial No. PFZ228501H, PFZ228504H, PFZ228590H, PFZ228836H, PFZ228838H, PFZ229236H, PFZ229520H), 00643169314092 (Serial No. PFZ223779H, PFZ214605H) (EXPANSION: Serial No. PFZ203846H, PFZ200814H, PFZ202951H, PFZ203501H, PFZ203757H, PFZ204555H, PFZ206452H, PFZ206453H, PFZ206456H, PFZ206595H, PFZ206712H, PFZ206881H, PFZ206900H, PFZ209342H, PFZ209675H, PFZ210215H, PFZ210528H, PFZ210537H, PFZ210538H, PFZ210539H, PFZ210791H, PFZ214550H, PFZ214823H, PFZ214971H, PFZ215285H, PFZ215626H, PFZ215627H, PFZ215630H, PFZ215631H, PFZ215876H, PFZ216099H, PFZ216100H, PFZ216973H, PFZ216974H, PFZ217247H, PFZ218221H, PFZ218432H, PFZ218433H, PFZ218435H, PFZ218436H, PFZ218437H, PFZ218877H, PFZ219142H, PFZ219143H, PFZ219373H, PFZ220377H, PFZ221425H, PFZ221716H, PFZ221724H, PFZ221725H, PFZ221726H, PFZ222665H, PFZ223869H, PFZ225847H, PFZ225849H, PFZ225850H, PFZ225851H, PFZ225852H, PFZ225854H, PFZ226023H, PFZ226092H, PFZ226179H, PFZ226185H, PFZ226442H, PFZ226443H, PFZ226513H, PFZ226586H, PFZ226924H, PFZ227065H, PFZ227408H, PFZ227453H, PFZ227454H, PFZ227455H, PFZ227456H, PFZ227778H, PFZ227779H, PFZ227780H, PFZ227781H, PFZ228380H, PFZ228459H, PFZ228560H, PFZ229000H, PFZ229904H, PFZ230774H, PFZ210536H, PFZ215361H, PFZ222655H, PFZ218434H, PFZ225120H, PFZ225848H, PFZ226091H, PFZ236813H, PFZ236991H, PFZ230454H); c. Product No. DVMB1D4: UDI 00643169314153 (Serial No. PKZ203327H, PKZ210673H) (EXPANSION: Serial No. PKZ202755H, PKZ203168H, PKZ204640H, PKZ205375H, PKZ205377H, PKZ206276H, PKZ206383H, PKZ208113H, PKZ208114H, PKZ208527H, PKZ208981H, PKZ210816H, PKZ210819H, PKZ210927H, PKZ210928H, PKZ210939H, PKZ211270H, PKZ211617H, PKZ211619H, PKZ211620H, PKZ211715H, PKZ210817H, PKZ211289H); d. Product No. DDMC3D1: UDI 00643169717244 (Serial No. CWC200055H); EXPANSION: e. Product No. DDMC3D4: UDI 00643169314139 (Serial No. PHZ201438H)
Z-0586-2018	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H); b. Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H); EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H); d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)
Z-0587-2018	Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DDBC3D1: UDI 00643169018044 (Serial No. BWG204574H) (EXPANSION: Serial No. BWG200861H, BWG201119H, BWG201913H, BWG204028H, BWG204300H, BWG205740H, BWG205936H, BWG206156H, BWG206745H, BWG206747H, BWG206882H, BWG206883H, BWG206884H, BWG206885H, BWG207389H, BWG207390H); b. Product No. DVBC3D1: UDI 00643169929852 (Serial No. BWM204635H), 00643169017900 (Serial No. BWM204192H) (EXPANSION: Serial No. BWM201169H, BWM202293H, BWM203256H, BWM203852H, BWM200338H, BWM203851H, BWM204508H); c. Product No. DVBC3D4: UDI 00643169017887 (Serial No. BWL204405H) (EXPANSION: Serial No. BWL202873H, BWL203306H, BWL203955H, BWL205870H, BWL201180H, BWL202937H, BWL205860H); d. Product No. DDBB1D1: UDI 00643169018099 (Serial No. BWC223253H, BWC201978H), 00643169530263 (Serial No. BWC233374H, BWC234767H, BWC234772H) (EXPANSION: Serial No. BWC236143H, BWC214218H, BWC201100H, BWC203011H, BWC203472H, BWC204674H, BWC205108H, BWC206553H, BWC206785H, BWC207821H, BWC207822H, BWC207823H, BWC210629H, BWC212493H, BWC214272H, BWC214763H, BWC216241H, BWC217842H, BWC217843H, BWC217844H, BWC218221H, BWC218224H, BWC224331H, BWC226302H, BWC226305H, BWC226657H, BWC227492H, BWC227493H, BWC228308H, BWC228309H, BWC228351H, BWC228836H, BWC229030H, BWC229087H, BWC231807H, BWC231876H, BWC231928H, BWC232958H, BWC234187H, BWC234515H, BWC234517H, BWC234518H, BWC234519H, BWC234522H, BWC234525H, BWC234559H, BWC234722H, BWC235087H, BWC235655H, BWC235967H, BWC235968H, BWC235969H, BWC236085H, BWC236087H, BWC236140H, BWC236141H, BWC236142H, BWC236144H, BWC236182H, BWC236290H, BWC236722H, BWC236723H, BWC236724H, BWC236775H, BWC237274H, BWC238797H, BWC239432H, BWC239866H, BWC216082H, BWC218086H, BWC224128H), 00643169929111 (Serial No. BWC240255H, BWC241043H); e. Product No. DVBB1D1: UDI 00643169017955 (Serial No. BWI208876H) (EXPANSION: Serial No. BWI209212H, BWI200678H, BWI200679H, BWI200980H, BWI202079H, BWI204182H, BWI204201H, BWI206252H, BWI208151H, BWI209159H, BWI209879H, BWI212202H, BWI214590H, BWI215505H, BWI215752H, BWI216623H, BWI216981H, BWI217952H, BWI217739H, BWI217941H, BWI218177H, BWI211281H, BWI217953H, BWI217955H); f. Product No. DVBB1D4: UDI 00643169017948 (Serial No. BWH201158H, BWH214640H) (EXPANSION: Serial No. BWH203008H, BWH203759H, BWH207797H, BWH209311H, BWH209313H, BWH210341H, BWH211052H, BWH211053H, BWH212583H, BWH212739H, BWH212740H, BWH213523H, BWH213531H, BWH214545H, BWH214546H, BWH217150H, BWH217312H, BWH218316H, BWH218386H, BWH219837H, BWH220818H, BWH221001H, BWH222521H, BWH224286H, BWH224297H, BWH223806H); EXPANSION: g. Product No. DDBC3D4: UDI 00643169018020 (Serial No. BWF200823H, BWF204395H, BWF206087H, BWF201831H, BWF202542H, BWF205758H, BWF201407H, BWF203531H, BWF205759H, BWF205852H); h. Product No. DDBB1D1G: UDI 00643169777606 (Serial No. BWC235910H); i. Product No. DDBB1D4: UDI 00643169018082 (Serial No. BWB206139H, BWB218529H, BWB201323H, BWB202548H, BWB202741H, BWB203522H, BWB203524H, BWB203525H, BWB203527H, BWB203528H, BWB203529H, BWB204481H, BWB205332H, BWB206095H, BWB206099H, BWB206476H, BWB207118H, BWB210704H, BWB212480H, BWB212482H, BWB212577H, BWB217513H, BWB218439H, BWB218616H, BWB218957H, BWB220702H, BWB221924H, BWB222431H, BWB223026H, BWB223413H, BWB224318H, BWB227088H, BWB229740H, BWB230009H, BWB230011H, BWB230116H, BWB203526H, BWB211923H, BWB229726H)
Z-0588-2018	Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DVFB1D1: UDI 00643169717213 (Serial No. CWG200402H) (EXPANSION: Serial No. CWG200403H, CWG200404H, CWG200406H, CWG200897H, CWG200898H, CWG202225H, CWG202244H, CWG202762H, CWG203250H, CWG203455H, CWG200147H, CWG200899H, CWG202761H); b. Product No. DVFB1D4: UDI 00643169566422 (Serial No. PKX202448H, PKX205417H, PKX205779H, PKX209277H) (EXPANSION: Serial No. PKX211818H, PKX201092H, PKX201561H, PKX201910H, PKX202355H, PKX202386H, PKX202879H, PKX202881H, PKX202882H, PKX202883H, PKX202884H, PKX202885H, PKX202960H, PKX203135H, PKX203209H, PKX203946H, PKX203947H, PKX203950H, PKX204060H, PKX204170H, PKX204372H, PKX204490H, PKX204625H, PKX204629H, PKX204640H, PKX205178H, PKX205179H, PKX205181H, PKX205239H, PKX205240H, PKX205268H, PKX205269H, PKX205659H, PKX205660H, PKX205661H, PKX205662H, PKX205663H, PKX205665H, PKX205666H, PKX205673H, PKX205774H, PKX206142H, PKX206740H, PKX206996H, PKX207013H, PKX207619H, PKX207870H, PKX208254H, PKX209305H, PKX210996H, PKX211165H, PKX211167H, PKX211168H, PKX211169H, PKX211170H, PKX211195H, PKX211196H, PKX211198H, PKX211222H, PKX211223H, PKX211226H, PKX211499H, PKX211847H, PKX211848H, PKX212194H, PKX212195H, PKX212196H, PKX212363H, PKX212763H, PKX212873H, PKX213476H, PKX213477H, PKX213633H, PKX214090H, PKX214355H, PKX214374H, PKX215541H, PKX210995H, PKX210999H, PKX211000H, PKX211029H, PKX211031H, PKX212362H, PKX211654H, PKX212197H), 00643169929913 (Serial No. PKX212710H, PKX213420H); EXPANSION: c. Product No. DVFC3D1: UDI 00643169717206 (Serial No. CWJ200155H); d. Product No. DVFC3D4: UDI 00643169566446 (Serial No. PMX200139H)
Z-0589-2018	Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).; a. Product No. DVAB1D1: UDI 00643169566347 (Serial No. BWN201126H) (EXPANSION: Serial No. BWN202016H, BWN202327H, BWN202334H, BWN202335H); EXPANSION: b. Product No. DVAB1D4: UDI 00643169566354 (Serial No. BWP201614H, BWP201658H, BWP201660H, BWP201669H, BWP201782H, BWP201783H), 00643169929760 (Serial No. BWP201661H)

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the product number and serial number on your device's label to confirm if it is affected.
Contact Medtronic
Reach out to Medtronic directly to confirm if your device is affected and get instructions for next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

Dec 19, 2017Firm started the recall
Feb 28, 2018Published in FDA’s Enforcement Report
Apr 19, 2018FDA classified it Class I
Aug 27, 2021FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Medtronic recalls

Link to this recall

<a href="https://govinfonow.com/recall/72274-medtronic-icds-risk-of-therapy-prevention-in-heart-devices">Medtronic ICDs: Risk of Therapy Prevention in Heart Devices (GovInfoNow)</a>

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-0585-2018 (December 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0585-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.