Recall archive / FDA device enforcement

ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators — FDA record Z-1818-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
Reason: 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.
Classification: Class I
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity: 2000 units
Agency-reported status: Ongoing
Source record identifier: Z-1818-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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RSC601503S, RSC602305S, RSC602398S, RSC602399S, RSC602400S, RSC602419S, RSC6...

Label field

Details supplied by the agency

Lot, code or applicability

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, RSC601545S, RSC601547S, RSC601551S, RSC601552S, RSC601553S, RSC601554S, RSC601577S, RSC601578S, RSC601579S, RSC601581S, RSC601848S, RSC601849S, RSC601850S, RSC601851S, RSC601852S, RSC602062S, RSC602335S, RSC602430S, RSC602431S, RSC602432S, RSC602434S, RSC601022S, RSC601106S, RSC601107S, RSC601183S, RSC601366S, RSC601368S, RSC602107S, RSC600224S, RSC602459S, RSC600283S, RSC601978S, RSC601643S, RSC600137S, RSC600233S, RSC601024S, RSC601112S, RSC601198S, RSC601347S, RSC601350S, RSC601369S, RSC601374S, RSC601426S, RSC601504S, RSC601654S, RSC601834S, RSC601904S, RSC601909S, RSC601693S, RSC601200S, RSC601184S, RSC601453S, RSC601467S, RSC601484S, RSC601193S, RSC601137S, RSC601139S, RSC601160S, RSC601641S, RSC602169S, RSC601177S, RSC601181S, RSC601907S, RSC602134S, RSC601195S, RSC601636S, RSC601831S, RSC602528S, RSC602008S, RSC602009S, RSC602754S, RSC601436S, RSC601877S, RSC600429S, RSC601202S, RSC602495S, RSC600519S, RSC600205S, RSC600437S, RSC600484S, RSC601901S, RSC602147S, RSC600450S, RSC601187S, RSC602496S, RSC600361S, RSC601251S, RSC602208S, RSC601644S, RSC601662S, RSC601663S, RSC601664S, RSC601666S, RSC601667S, RSC601668S, RSC601669S, RSC601671S, RSC601672S, RSC601673S, RSC601675S, RSC601861S, RSC601862S, RSC601863S, RSC601864S, RSC601865S, RSC601866S, RSC601867S, RSC601868S, RSC602397S, RSC602323S, RSC600141S, RSC600173S, RSC600179S, RSC600183S, RSC600194S, RSC600201S, RSC600203S, RSC600209S, RSC600218S, RSC600219S, RSC600221S, RSC600226S, RSC600239S, RSC600242S, RSC600252S, RSC600262S, RSC600325S, RSC600351S, RSC600390S, RSC600408S, RSC600416S, RSC600427S, RSC600431S, RSC600438S, RSC600441S, RSC600492S, RSC600498S, RSC601182S, RSC601908S, RSC602227S, RSC602324S, RSC602109S, RSC600292S, RSC600495S, RSC600496S, RSC600497S, RSC601655S, RSC601656S, RSC601659S, RSC601389S, RSC602371S, RSC601089S, RSC601379S, RSC600346S, RSC601161S, RSC600187S, RSC601442S, RSC602222S, RSC602491S, RSC601977S, RSC602099S, RSC602210S, RSC602224S, RSC602226S, RSC600134S, RSC601118S, RSC601140S, RSC601392S, RSC601440S, RSC601916S, RSC602116S, RSC602119S, RSC602124S, RSC602125S, RSC602126S, RSC601528S, RSC601609S, RSC601610S, RSC601895S, RSC601896S, RSC601897S, RSC601898S, RSC601899S, RSC602117S, RSC602120S, RSC602121S, RSC602122S, RSC602123S, RSC601165S, RSC601403S, RSC600504S, RSC601030S, RSC601091S, RSC601122S, RSC601432S, RSC601620S, RSC600480S, RSC602326S, RSC600323S, RSC602014S, RSC600353S, RSC601109S, RSC601517S, RSC601625S, RSC602142S, RSC602767S, RSC601076S, RSC601086S, RSC601090S, RSC601151S, RSC602026S, RSC602129S, RSC602633S, RSC602694S, RSC601622S, RSC601377S, RSC601378S, RSC601381S, RSC601382S, RSC601912S, RSC601514S, RSC601036S, RSC601881S, RSC601145S, RSC602413S, RSC602414S, RSC602418S, RSC602423S, RSC602422S, RSC602682S, RSC602813S, RSC602086S, RSC602088S, RSC602089S, RSC602823S, RSC600249S, RSC601522S, RSC601642S, RSC602265S, RSC602702S, RSC601174S, RSC600206S, RSC600402S, RSC600418S, RSC601469S, RSC601470S, RSC602100S, RSC601893S, RSC600348S, RSC600475S, RSC601697S, RSC601424S, RSC602246S, RSC602461S, RSC601712S, RSC601890S, RSC602730S, RSC601951S, RSC601953S, RSC602376S, RSC601358S, RSC600264S, RSC600279S, RSC601120S, RSC601974S, RSC602297S, RSC602298S, RSC602475S, RSC602712S, RSC600306S, RSC600395S, RSC600412S, RSC601888S, RSC602328S, RSC600514S, RSC600320S, RSC600517S, RSC601085S, RSC602574S, RSC601110S, RSC602319S, RSC600143S, RSC602160S, RSC602290S, RSC600129S, RSC600300S, RSC601404S, RSC602437S, RSC602579S, RSC602766S, RSC600156S, RSC602464S, RSC602284S, RSC602161S, RSC602266S, RSC602307S, RSC602763S, RSC601092S, RSC601154S, RSC602215S, RSC602401S, RSC602686S, RSC602687S, RSC602216S, RSC600172S, RSC600214S, RSC600370S, RSC602346S, RSC602347S, RSC602372S, RSC602293S, RSC601395S, RSC601166S, RSC601343S, RSC601838S, RSC600178S, RSC601096S, RSC600148S, RSC600199S, RSC600269S, RSC601513S, RSC601431S, RSC601982S, RSC601095S, RSC601143S, RSC601483S, RSC602446S, RSC601401S, RSC602015S, RSC600485S, RSC601542S, RSC601882S, RSC602695S, RSC602808S, RSC602011S, RSC602012S, RSC602148S, RSC602309S, RSC601950S, RSC602492S, RSC602641S, RSC600493S, RSC601476S, RSC601482S, RSC601906S, RSC602576S, RSC602617S, RSC600398S, RSC601277S, RSC601288S, RSC601464S, RSC601652S, RSC602738S, RSC601844S, RSC601845S, RSC601847S, RSC601201S, RSC601399S, RSC602060S, RSC600445S, RSC602606S, RSC601114S, RSC601313S, RSC601317S, RSC601339S, RSC601356S, RSC601911S, RSC601637S, RSC601495S, RSC601354S, RSC601491S, RSC601674S, RSC600404S, RSC601178S, RSC602451S, RSC602448S, RSC602688S, RSC602749S, RSC602748S, RSC601209S, RSC601348S, RSC602781S, RSC602782S, RSC601191S, RSC601077S, RSC601138S, RSC601204S, RSC601633S, RSC601634S, RSC600516S, RSC602113S, RSC601902S, RSC601136S, RSC601211S, RSC601312S, RSC602207S, RSC602354S, RSC602353S, RSC601523S, RSC600192S, RSC601094S, RSC600161S, RSC601981S, RSC602623S, RSC602575S, RSC601390S, RSC601645S, RSC602436S, RSC601190S, RSC602115S, RSC602814S, RSC602151S, RSC602152S, RSC601020S, RSC601088S, RSC601093S, RSC601220S, RSC601224S, RSC601319S, RSC601394S, RSC602141S, RSC600132S, RSC600157S, RSC600230S, RSC601069S, RSC601148S, RSC601189S, RSC601340S, RSC601477S, RSC602241S, RSC601856S, RSC602039S, RSC601185S, RSC601487S, RSC601499S, RSC601512S, RSC601526S, RSC601531S, RSC601613S, RSC601688S, RSC601713S, RSC601857S, RSC601858S, RSC601860S, RSC601915S, RSC601941S, RSC601262S, RSC601275S, RSC601918S, RSC600330S, RSC600146S, RSC601034S, RSC601454S, RSC601481S, RSC600145S, RSC601098S, RSC601102S, RSC601104S, RSC601411S, RSC601412S, RSC601488S, RSC601875S, RSC602238S, RSC601725S, RSC601255S, RSC601507S, RSC601087S, RSC602405S, RSC602408S, RSC601233S, RSC601234S, RSC601235S, RSC601236S, RSC601237S, RSC601238S, RSC601583S, RSC601585S, RSC601586S, RSC601587S, RSC601698S, RSC601701S, RSC601709S, RSC602403S, RSC602404S, RSC602406S, RSC602407S, RSC602409S, RSC601150S, RSC601917S, RSC601919S, RSC601920S, RSC601922S, RSC601925S, RSC601926S, RSC601939S, RSC602631S, RSC602336S, RSC602536S, RSC602753S, RSC601257S, RSC602211S, RSC602357S, RSC602204S, RSC600182S, RSC600204S, RSC600210S, RSC600295S, RSC600356S, RSC600393S, RSC600415S, RSC600435S, RSC600481S, RSC601031S, RSC601441S, RSC602385S, RSC601970S, RSC602380S, RSC602381S, RSC602478S, RSC601067S, RSC601074S, RSC601167S, RSC601405S, RSC601618S, RSC601689S, RSC601695S, RSC601128S, RSC602081S, RSC601029S, RSC601619S, RSC602003S, RSC601614S, RSC600165S, RSC601039S, RSC600277S, RSC600375S, RSC600377S, RSC600388S, RSC600466S, RSC600473S, RSC600478S, RSC601123S, RSC601125S, RSC601496S, RSC602318S, RSC602325S, RSC602602S, RSC602622S, RSC602315S, RSC602167S, RSC601075S, RSC601078S, RSC601346S, RSC601243S, RSC601957S, RSC600288S, RSC600329S, RSC602761S, RSC602472S, RSC602303S, RSC600235S, RSC601889S, RSC600387S, RSC600455S, RSC600464S, RSC601365S, RSC600332S, RSC600336S, RSC602320S, RSC600258S, RSC600503S, RSC601116S, RSC601142S, RSC601250S, RSC602630S, RSC602150S, RSC601699S, RSC601914S, RSC601859S, RSC601952S, RSC602302S, RSC602382S, RSC600127S, RSC600138S, RSC600349S, RSC600369S, RSC600451S, RSC601171S, RSC601180S, RSC601261S, RSC601391S, RSC601616S, RSC601617S, RSC602170S, RSC602237S, RSC601886S, RSC601323S, RSC601337S, RSC601627S, RSC601628S, RSC601651S, RSC601680S, RSC601681S, RSC601715S, RSC601719S, RSC601732S, RSC601756S, RSC600280S, RSC601113S, RSC601219S, RSC601429S, RSC601063S, RSC602639S, RSC602402S, RSC602493S, RSC602494S, RSC602304S, RSC600334S, RSC600384S, RSC601459S, RSC601460S, RSC602242S, RSC601361S, RSC601494S, RSC600268S, RSC602454S, RSC601247S, RSC602713S, RSC601068S, RSC601073S, RSC601199S, RSC602618S, RSC600499S, RSC602236S, RSC600428S, RSC601021S, RSC601505S, RSC600474S, RSC601511S, RSC602450S, RSC602166S, RSC601726S, RSC600231S, RSC602299S, RSC602159S, RSC601100S, RSC601103S, RSC601696S, RSC602580S, RSC601685S, RSC601035S, RSC601510S, RSC601188S, RSC600285S, RSC601027S, RSC601108S, RSC602395S, RSC602396S, RSC601988S, RSC601159S, RSC601131S, RSC601979S, RSC601083S, RSC600296S, RSC601079S, RSC601518S, RSC602489S, RSC602239S, RSC602240S, RSC600924S, RSC601196S, RSC601207S, RSC600471S, RSC601621S, RSC601905S, RSC602374S, RSC600303S, RSC600444S, RSC602112S, RSC600494S, RSC601176S, RSC601885S, RSC602560S, RSC602691S, RSC602692S, RSC602689S, RSC602690S, RSC602820S, RSC601254S, RSC601536S, RSC602212S, RSC601135S, RSC601475S, RSC601530S, RSC601891S, RSC602658S, RSC602158S, RSC601032S, RSC602498S, RSC602822S, RSC600414S, RSC602163S, RSC601105S, RSC600355S, RSC600477S, RSC601435S, RSC601519S, RSC601694S, RSC601945S, RSC601245S, RSC601479S, RSC600150S, RSC601437S, RSC601653S, RSC600467S, RSC602321S, RSC602674S, RSC601192S, RSC601497S, RSC601498S, RSC601589S, RSC601639S, RSC601708S, RSC601837S, RSC602384S, RSC600130S, RSC601210S, RSC602310S, RSC602383S, RSC602230S, RSC602744S, RSC602693S, RSC602282S, RSC601203S, RSC601218S, RSC601623S, RSC600333S, RSC601434S, RSC600345S, RSC600358S, RSC601099S, RSC600159S, RSC601508S, RSC600468S, RSC601418S, RSC602801S, RSC602342S, RSC600273S, RSC601213S, RSC602772S, RSC601611S, RSC602535S, RSC600365S, RSC600360S, RSC601344S, RSC602410S, RSC602110S, RSC602172S, RSC602251S, RSC602261S, RSC600181S, RSC600251S, RSC600447S, RSC600491S, RSC601115S, RSC601117S, RSC601439S, RSC601626S, RSC601879S, RSC601903S, RSC601913S, RSC601129S, RSC601130S, RSC601132S, RSC601133S, RSC602214S, RSC602337S, RSC602338S, RSC602339S, RSC602340S, RSC602352S, RSC601387S, RSC601398S, RSC601878S, RSC602103S, RSC602218S, RSC600340S, RSC600341S, RSC600350S, RSC600385S, RSC601169S, RSC601194S, RSC601253S, RSC601380S, RSC601384S, RSC601385S, RSC601386S, RSC601406S, RSC601409S, RSC601478S, RSC602221S, RSC602228S, RSC600326S, RSC601527S, RSC602165S, RSC600248S, RSC600335S, RSC600359S, RSC601124S, RSC601355S, RSC601421S, RSC601635S, RSC601894S, RSC600019S, RSC600260S, RSC602327S, RSC601097S, RSC601592S, RSC601876S, RSC601648S, RSC602245S, RSC602854S, RSC602316S, RSC600263S, RSC601375S, RSC602146S, RSC601359S, RSC602345S, RSC601119S, RSC601144S, RSC600139S, RSC600142S, RSC600274S, RSC600343S, RSC600366S, RSC600374S, RSC600376S, RSC601080S, RSC601521S, RSC601539S, RSC601892S, RSC601023S, RSC602322S, RSC600246S, RSC602488S, RSC602722S, RSC602723S, RSC600168S, RSC600180S, RSC601329S, RSC601383S, RSC601989S, RSC601993S, RSC602217S, RSC601126S, RSC602206S, RSC601252S, RSC601121S, RSC602080S, RSC602092S, RSC602093S, RSC602095S, RSC602096S, RSC602361S, RSC602362S, RSC602363S, RSC602364S, RSC602365S, RSC602366S, RSC602367S, RSC602368S, RSC602369S, RSC602370S, RSC602537S, RSC602538S, RSC602541S, RSC602542S, RSC602545S, RSC602546S, RSC602552S, RSC602696S, RSC602697S, RSC602698S, RSC602699S, RSC602700S, RSC602428S, RSC602429S, RSC602685S, RSC602114S, RSC602683S, RSC602684S, RSC601503S, RSC602305S, RSC602398S, RSC602399S, RSC602400S, RSC602419S, RSC6...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide - Worldwide Distribution

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 28, 2023
Recall initiation date: May 10, 2023
Center classification date: Jun 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records