Recall archive / FDA device enforcement

ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators — FDA record Z-1726-2023

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 DR MRI IS1 DF4, Model Number DDPB3D4; 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: 11,645 units
Agency-reported status: Ongoing
Source record identifier: Z-1726-2023

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
Lot, code or applicability	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, 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RSO605711S, RSO610419S, RSO603576S, RSO609646S, RSO610502S, RSO612017S, RSO612057S, RSO601493S, RSO606259S, RSO606538S, RSO607174S, RSO607283S, RSO608560S, RSO608599S, RSO613123S, RSO610585S, RSO611639S, RSO601068S, RSO603452S, RSO604575S, RSO604761S, RSO605092S, RSO606546S, RSO606766S, RSO606962S, RSO608026S, RSO611718S, RSO606519S, RSO606852S, RSO600251S, RSO601170S, RSO603094S, RSO603240S, RSO603373S, RSO609551S, RSO610587S, RSO611731S, RSO600180S, RSO600481S, RSO600922S, RSO601430S, RSO601685S, RSO610794S, RSO611643S, RSO612225S, RSO612474S, RSO612541S, RSO612619S, RSO608456S, RSO612706S, RSO609749S, RSO609886S, RSO610558S, RSO610975S, RSO611569S, RSO612069S, RSO612135S, RSO612491S, RSO612560S, RSO601505S, RSO601728S, RSO602755S, RSO604245S, RSO604250S, RSO604448S, RSO604564S, RSO605197S, RSO605311S, RSO605622S, RSO605667S, RSO605828S, RSO605844S, RSO606275S, RSO606357S, RSO606409S, RSO606485S, RSO607041S, RSO607055S, RSO607092S, RSO607105S, RSO607109S, RSO607134S, RSO607149S, 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RSO611806S, RSO600864S, RSO600965S, RSO601039S, RSO601174S, RSO601178S, RSO6...

Label field

Details supplied by the agency

Lot, code or applicability

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, RSO604477S, RSO604521S, RSO604971S, RSO604986S, RSO605288S, RSO605313S, RSO606154S, RSO606633S, RSO606984S, RSO607027S, RSO607059S, RSO607060S, RSO607066S, RSO607258S, RSO609917S, RSO601016S, RSO602843S, RSO603638S, RSO603828S, RSO603945S, RSO604008S, RSO604027S, RSO604176S, RSO607364S, RSO607365S, RSO608201S, RSO600768S, RSO602527S, RSO601005S, RSO601737S, RSO610417S, RSO601500S, RSO610630S, RSO612087S, RSO612192S, RSO612270S, RSO612547S, RSO610576S, RSO611766S, RSO611771S, RSO611773S, RSO600905S, RSO601136S, RSO601571S, RSO602734S, RSO603672S, RSO605325S, RSO606464S, RSO606516S, RSO607087S, RSO607179S, RSO607202S, RSO607203S, RSO607602S, RSO602875S, RSO602876S, RSO602877S, RSO602878S, RSO602880S, RSO602881S, RSO602882S, RSO602883S, RSO602884S, RSO604398S, RSO604416S, RSO604417S, RSO604418S, RSO604419S, RSO604420S, RSO604421S, RSO604422S, RSO604423S, RSO604424S, RSO604425S, RSO604426S, RSO604428S, RSO600619S, RSO602618S, RSO603959S, RSO603960S, RSO603961S, RSO604005S, RSO611972S, RSO611973S, RSO601416S, RSO606602S, RSO602744S, RSO603285S, RSO603286S, RSO603946S, RSO604015S, RSO604499S, RSO604965S, RSO605434S, RSO605526S, RSO605827S, RSO605981S, RSO605996S, RSO606140S, RSO606182S, RSO606990S, RSO608017S, RSO605212S, RSO607379S, RSO600542S, RSO601565S, RSO604252S, RSO604674S, RSO608842S, RSO609738S, RSO609739S, RSO610464S, RSO610539S, RSO610961S, RSO610967S, RSO611676S, RSO612239S, RSO612640S, RSO600675S, RSO600875S, RSO600876S, RSO600889S, RSO601564S, RSO601672S, RSO601692S, RSO601745S, RSO601752S, RSO603092S, RSO603653S, RSO603692S, RSO604011S, RSO604122S, RSO604251S, RSO605012S, RSO605236S, RSO605513S, RSO605821S, RSO605893S, RSO605916S, RSO606459S, RSO606528S, RSO606540S, RSO606965S, RSO606966S, RSO607237S, RSO607994S, RSO608027S, RSO608841S, RSO609002S, RSO609003S, RSO609670S, RSO609759S, RSO610510S, RSO610637S, RSO610767S, RSO611793S, RSO612692S, RSO600826S, RSO601006S, RSO601007S, RSO601044S, RSO601778S, RSO602544S, RSO602645S, RSO602707S, RSO602789S, RSO602846S, RSO603570S, RSO603710S, RSO604003S, RSO604012S, RSO604158S, RSO605435S, RSO606448S, RSO607739S, RSO600997S, RSO601143S, RSO601144S, RSO602895S, RSO602925S, RSO603346S, RSO609665S, RSO611127S, RSO600710S, RSO605598S, RSO606058S, RSO610370S, RSO603034S, RSO603711S, RSO604060S, RSO611419S, RSO601756S, RSO601825S, RSO601828S, RSO601866S, RSO604240S, RSO604519S, RSO607211S, RSO607250S, RSO608553S, RSO612321S, RSO609837S, RSO610453S, RSO610561S, RSO610850S, RSO610851S, RSO612544S, RSO607226S, RSO612324S, RSO601331S, RSO601813S, RSO606333S, RSO608018S, RSO600400S, RSO600959S, RSO601134S, RSO601383S, RSO609594S, RSO612179S, RSO601175S, RSO601915S, RSO603815S, RSO605975S, RSO607858S, RSO608939S, RSO611580S, RSO611744S, RSO605075S, RSO605076S, RSO605083S, RSO605086S, RSO605094S, RSO605099S, RSO605103S, RSO605105S, RSO605110S, RSO610959S, RSO600716S, RSO600717S, RSO600924S, RSO601179S, RSO601244S, RSO601335S, RSO601395S, RSO601396S, RSO601523S, RSO601731S, RSO603166S, RSO603488S, RSO603608S, RSO603702S, RSO604495S, RSO604497S, RSO604557S, RSO604558S, RSO605031S, RSO605616S, RSO607022S, RSO607597S, RSO607601S, RSO607654S, RSO607995S, RSO608747S, RSO609006S, RSO604814S, RSO600698S, RSO601710S, RSO602323S, RSO602936S, RSO605037S, RSO601130S, RSO600845S, RSO603422S, RSO603798S, RSO604962S, RSO608238S, RSO608535S, RSO608792S, RSO602340S, RSO605028S, RSO605417S, RSO606314S, RSO610970S, RSO602377S, RSO602378S, RSO602407S, RSO602408S, RSO602413S, RSO602417S, RSO603643S, RSO603644S, RSO603897S, RSO604383S, RSO604384S, RSO604385S, RSO604387S, RSO604388S, RSO604389S, RSO604390S, RSO604391S, RSO604392S, RSO604393S, RSO604394S, RSO604395S, RSO604396S, RSO604397S, RSO604399S, RSO603426S, RSO609731S, RSO610709S, RSO610719S, RSO611384S, RSO612126S, RSO612242S, RSO612350S, RSO612519S, RSO612520S, RSO603687S, RSO603908S, RSO604002S, RSO605098S, RSO605753S, RSO605884S, RSO606130S, RSO606219S, RSO606470S, RSO606969S, RSO607563S, RSO607594S, RSO607874S, RSO607875S, RSO607926S, RSO608386S, RSO608595S, RSO608617S, RSO608997S, RSO601321S, RSO605761S, RSO609630S, RSO610819S, RSO611142S, RSO612129S, RSO612309S, RSO612311S, RSO604624S, RSO604625S, RSO604626S, RSO606560S, RSO606981S, RSO607350S, RSO607959S, RSO608256S, RSO609612S, RSO610710S, RSO611571S, RSO611577S, RSO611708S, RSO612010S, RSO612011S, RSO612168S, RSO612178S, RSO601158S, RSO604260S, RSO605063S, RSO605130S, RSO605494S, RSO605496S, RSO605732S, RSO606265S, RSO606339S, RSO606536S, RSO607823S, RSO607900S, RSO607934S, RSO608024S, RSO608615S, RSO608663S, RSO608694S, RSO609256S, RSO609296S, RSO609415S, RSO609583S, RSO609631S, RSO609842S, RSO609905S, RSO610347S, RSO610497S, RSO610836S, RSO610837S, RSO610839S, RSO611616S, RSO611617S, RSO612049S, RSO612050S, RSO612051S, RSO612267S, RSO612330S, RSO612331S, RSO612511S, RSO600862S, RSO600910S, RSO600912S, RSO600913S, RSO600914S, RSO600915S, RSO600916S, RSO601240S, RSO601243S, RSO601300S, RSO601361S, RSO601563S, RSO601690S, RSO601887S, RSO601929S, RSO602758S, RSO602889S, RSO602958S, RSO603071S, RSO603579S, RSO603590S, RSO603595S, RSO603821S, RSO603831S, RSO603890S, RSO603903S, RSO603910S, RSO603971S, RSO603984S, RSO604086S, RSO604588S, RSO604870S, RSO605005S, RSO605006S, RSO605101S, RSO605218S, RSO605253S, RSO605262S, RSO605361S, RSO605395S, RSO605412S, RSO605765S, RSO605883S, RSO605890S, RSO606120S, RSO606143S, RSO606268S, RSO606500S, RSO606557S, RSO606604S, RSO606662S, RSO606663S, RSO606777S, RSO607101S, RSO607199S, RSO607200S, RSO607256S, RSO607325S, RSO607960S, RSO608051S, RSO608053S, RSO608258S, RSO608305S, RSO608309S, RSO608473S, RSO608478S, RSO608566S, RSO608568S, RSO608622S, RSO608625S, RSO608716S, RSO608769S, RSO608771S, RSO608947S, RSO608948S, RSO609142S, RSO609199S, RSO611980S, RSO611981S, RSO611982S, RSO611983S, RSO609632S, RSO609637S, RSO609849S, RSO609932S, RSO610429S, RSO610568S, RSO610742S, RSO611356S, RSO611655S, RSO612100S, RSO600676S, RSO600748S, RSO600891S, RSO600898S, RSO601114S, RSO601620S, RSO604023S, RSO604735S, RSO605729S, RSO606124S, RSO606320S, RSO606476S, RSO606501S, RSO606568S, RSO606615S, RSO607002S, RSO607123S, RSO607305S, RSO607307S, RSO607533S, RSO607856S, RSO607864S, RSO607910S, RSO607938S, RSO607945S, RSO607947S, RSO608333S, RSO608685S, RSO608810S, RSO608909S, RSO612282S, RSO601847S, RSO603623S, RSO604303S, RSO605413S, RSO605661S, RSO609667S, RSO609668S, RSO609954S, RSO609956S, RSO610952S, RSO610965S, RSO603312S, RSO604206S, RSO604265S, RSO604445S, RSO605120S, RSO605374S, RSO605398S, RSO605845S, RSO605888S, RSO605910S, RSO606295S, RSO606988S, RSO607607S, RSO607623S, RSO607922S, RSO607958S, RSO608292S, RSO608746S, RSO608845S, RSO609912S, RSO610854S, RSO611622S, RSO606255S, RSO607072S, RSO608032S, RSO608619S, RSO608777S, RSO609440S, RSO612130S, RSO607564S, RSO609509S, RSO601201S, RSO611621S, RSO612582S, RSO605340S, RSO605956S, RSO606832S, RSO610401S, RSO611661S, RSO600992S, RSO609581S, RSO610560S, RSO612191S, RSO612315S, RSO612540S, RSO605922S, RSO606125S, RSO608803S, RSO606956S, RSO605352S, RSO607025S, RSO601056S, RSO610487S, RSO612128S, RSO612165S, RSO606290S, RSO600183S, RSO600645S, RSO600678S, RSO600752S, RSO600911S, RSO601088S, RSO601412S, RSO601815S, RSO601830S, RSO601853S, RSO602450S, RSO602746S, RSO602763S, RSO602932S, RSO603060S, RSO603260S, RSO603379S, RSO603539S, RSO603704S, RSO603848S, RSO609350S, RSO600784S, RSO601665S, RSO601860S, RSO603380S, RSO605029S, RSO606349S, RSO612306S, RSO612566S, RSO600167S, RSO600168S, RSO600685S, RSO600686S, RSO600818S, RSO600879S, RSO600880S, RSO600881S, RSO600892S, RSO600893S, RSO600894S, RSO600895S, RSO601123S, RSO602625S, RSO602628S, RSO603229S, RSO603478S, RSO603629S, RSO603630S, RSO603657S, RSO603709S, RSO603727S, RSO605102S, RSO605254S, RSO605711S, RSO610419S, RSO603576S, RSO609646S, RSO610502S, RSO612017S, RSO612057S, RSO601493S, RSO606259S, RSO606538S, RSO607174S, RSO607283S, RSO608560S, RSO608599S, RSO613123S, RSO610585S, RSO611639S, RSO601068S, RSO603452S, RSO604575S, RSO604761S, RSO605092S, RSO606546S, RSO606766S, RSO606962S, RSO608026S, RSO611718S, RSO606519S, RSO606852S, RSO600251S, RSO601170S, RSO603094S, RSO603240S, RSO603373S, RSO609551S, RSO610587S, RSO611731S, RSO600180S, RSO600481S, RSO600922S, RSO601430S, RSO601685S, RSO610794S, RSO611643S, RSO612225S, RSO612474S, RSO612541S, RSO612619S, RSO608456S, RSO612706S, RSO609749S, RSO609886S, RSO610558S, RSO610975S, RSO611569S, RSO612069S, RSO612135S, RSO612491S, RSO612560S, RSO601505S, RSO601728S, RSO602755S, RSO604245S, RSO604250S, RSO604448S, RSO604564S, RSO605197S, RSO605311S, RSO605622S, RSO605667S, RSO605828S, RSO605844S, RSO606275S, RSO606357S, RSO606409S, RSO606485S, RSO607041S, RSO607055S, RSO607092S, RSO607105S, RSO607109S, RSO607134S, RSO607149S, RSO607415S, RSO607580S, RSO607636S, RSO607637S, RSO607896S, RSO608451S, RSO608604S, RSO608661S, RSO610410S, RSO610960S, RSO610966S, RSO610968S, RSO610428S, RSO603994S, RSO603997S, RSO604374S, RSO605178S, RSO605637S, RSO606023S, RSO606260S, RSO606364S, RSO606559S, RSO606595S, RSO608644S, RSO609833S, RSO610351S, RSO610384S, RSO610408S, RSO611399S, RSO611704S, RSO612207S, RSO612241S, RSO612650S, RSO612652S, RSO600975S, RSO601353S, RSO601593S, RSO601920S, RSO602397S, RSO602723S, RSO603207S, RSO604299S, RSO604310S, RSO604872S, RSO605157S, RSO605172S, RSO605224S, RSO605250S, RSO605281S, RSO605823S, RSO606370S, RSO606373S, RSO607294S, RSO607436S, RSO607817S, RSO610702S, RSO605300S, RSO607037S, RSO601739S, RSO605210S, RSO609806S, RSO612196S, RSO601209S, RSO612637S, RSO612638S, RSO612639S, RSO612710S, RSO612711S, RSO612712S, RSO610372S, RSO610641S, RSO600731S, RSO600732S, RSO600733S, RSO600811S, RSO600812S, RSO600816S, RSO600902S, RSO601062S, RSO601084S, RSO601140S, RSO601183S, RSO601279S, RSO601282S, RSO601284S, RSO601303S, RSO601798S, RSO601871S, RSO601878S, RSO601895S, RSO602873S, RSO602917S, RSO603070S, RSO603085S, RSO603170S, RSO603227S, RSO604070S, RSO604487S, RSO605205S, RSO607445S, RSO608191S, RSO608254S, RSO608579S, RSO608580S, RSO608630S, RSO608631S, RSO608653S, RSO609860S, RSO600267S, RSO600770S, RSO601471S, RSO603375S, RSO605306S, RSO605353S, RSO607148S, RSO607151S, RSO607794S, RSO609007S, RSO613216S, RSO609629S, RSO609817S, RSO611293S, RSO611574S, RSO611992S, RSO612206S, RSO612240S, RSO600955S, RSO603847S, RSO605100S, RSO605373S, RSO608237S, RSO608765S, RSO609011S, RSO610872S, RSO611790S, RSO600213S, RSO600216S, RSO600243S, RSO600872S, RSO600933S, RSO601148S, RSO601373S, RSO601628S, RSO602548S, RSO602592S, RSO602753S, RSO603013S, RSO603019S, RSO603790S, RSO604004S, RSO604124S, RSO604136S, RSO604200S, RSO604223S, RSO604945S, RSO605416S, RSO606838S, RSO609423S, RSO610969S, RSO611772S, RSO611785S, RSO609633S, RSO609636S, RSO609688S, RSO609856S, RSO609936S, RSO611806S, RSO600864S, RSO600965S, RSO601039S, RSO601174S, RSO601178S, RSO6...

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

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