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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78888

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

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).

Z-0582-2018
Recall number
Z-0582-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 2 of 8

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).

Z-0583-2018
Recall number
Z-0583-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 3 of 8

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).

Z-0584-2018
Recall number
Z-0584-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 4 of 8

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).

Z-0585-2018
Recall number
Z-0585-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 5 of 8

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).

Z-0586-2018
Recall number
Z-0586-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 6 of 8

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).

Z-0587-2018
Recall number
Z-0587-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 7 of 8

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).

Z-0588-2018
Recall number
Z-0588-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.

device · product 8 of 8

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).

Z-0589-2018
Recall number
Z-0589-2018
Initiated
December 19, 2017
Classification
Class I
Status
Terminated
Quantity
951 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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)

Distribution pattern

US Nationwide Distribution.