Recall archive / FDA device enforcement
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators — FDA record Z-1737-2023
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
- CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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
- 2904 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1737-2023
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 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S, BLI613418S, BLI613649S, BLI613879S, BLI614325S, BLI612962S, BLI613272S, BLI614595S, BLI613243S, BLI613284S, BLI614472S, BLI612753S, BLI613334S, BLI613664S, BLI612828S, BLI614463S, BLI614487S, BLI614772S, BLI614781S, BLI612721S, BLI612752S, BLI613693S, BLI613790S, BLI612950S, BLI613294S, BLI613331S, BLI613332S, BLI614173S, BLI614535S, BLI614831S, BLI612781S, BLI612956S, BLI613231S, BLI612717S, BLI612902S, BLI614784S, BLI613992S, BLI612937S, BLI614227S, BLI612867S, BLI614167S, BLI613452S, BLI614000S, BLI614043S, BLI614316S, BLI614586S, BLI613336S, BLI613415S, BLI613689S, BLI614182S, BLI612917S, BLI612941S, BLI612952S, BLI614147S, BLI613239S, BLI614587S, BLI614467S, BLI614474S, BLI613222S, BLI614218S, BLI613300S, BLI612908S, BLI614764S, BLI612778S, BLI613728S, BLI614769S, BLI612584S, BLI612764S, BLI614003S, BLI614575S, BLI613307S, BLI613224S, BLI613502S, BLI614759S, BLI612576S, BLI612837S, BLI614180S, BLI612558S, BLI612773S, BLI614027S, BLI614477S, BLI614573S, BLI614024S, BLI614581S, BLI612948S, BLI614321S, BLI614583S, BLI613695S, BLI613590S, BLI612755S, BLI613225S, BLI614569S, BLI614499S, BLI614200S, BLI614486S, BLI612963S, BLI613270S, BLI612772S, BLI612861S, BLI613764S, BLI612868S, BLI613214S, BLI613446S, BLI613368S, BLI614733S, BLI612847S, BLI612600S, BLI612841S, BLI613873S, BLI614295S, BLI614314S, BLI614580S, BLI614775S, BLI612453S, BLI612771S, BLI612783S, BLI612850S, BLI612957S, BLI613228S, BLI613238S, BLI613264S, BLI613279S, BLI613328S, BLI613451S, BLI613490S, BLI613603S, BLI613669S, BLI613677S, BLI613681S, BLI613775S, BLI613997S, BLI614234S, BLI614311S, BLI612942S, BLI613500S, BLI614747S, BLI613999S, BLI614209S, BLI614541S, BLI614724S, BLI612588S, BLI613262S, BLI613422S, BLI613586S, BLI614235S, BLI614306S, BLI612698S, BLI612862S, BLI612966S, BLI613325S, BLI614291S, BLI613420S, BLI612676S, BLI612678S, BLI612679S, BLI612680S, BLI612681S, BLI612686S, BLI612687S, BLI612689S, BLI612693S, BLI612829S, BLI612869S, BLI612870S, BLI612871S, BLI612872S, BLI612873S, BLI612874S, BLI612877S, BLI612883S, BLI612896S, BLI612898S, BLI612901S, BLI613298S, BLI613308S, BLI613330S, BLI613701S, BLI613704S, BLI613707S, BLI613716S, BLI613795S, BLI612840S, BLI612699S, BLI612757S, BLI613216S, BLI613235S, BLI613295S, BLI613717S, BLI614768S, BLI612802S, BLI612907S, BLI613654S, BLI614041S, BLI614162S, BLI614238S, BLI613303S, BLI614187S, BLI613794S, BLI613219S, BLI614774S, BLI614479S, BLI614739S, BLI612719S, BLI614544S, BLI613407S, BLI613673S, BLI613241S, BLI613798S, BLI612596S, BLI613256S, BLI613309S, BLI612909S, BLI613998S, BLI614014S, BLI614163S, BLI612597S, BLI613335S, BLI613990S, BLI614578S, BLI612903S, BLI613991S, BLI614217S, BLI614473S, BLI614297S, BLI613326S, BLI613770S, BLI613870S, BLI614225S, BLI614598S, BLI614815S, BLI613875S, BLI614465S, BLI614178S, BLI613313S, BLI614294S, BLI612581S, BLI613237S, BLI614317S, BLI613287S, BLI614236S, BLI613868S, BLI614582S, BLI614020S, BLI613283S, BLI614007S, BLI614222S, BLI614567S, BLI612951S, BLI613277S, BLI613421S, BLI613217S, BLI612939S, BLI613656S, BLI614017S, BLI614323S, BLI612949S, BLI613779S, BLI614459S, BLI613660S, BLI612803S, BLI612911S, BLI612921S, BLI613218S, BLI613221S, BLI613232S, BLI613242S, BLI613274S, BLI613292S, BLI613611S, BLI613661S, BLI613796S, BLI613861S, BLI612720S, BLI614480S, BLI612923S, BLI613678S, BLI614318S, BLI612459S, BLI612762S, BLI613223S, BLI613314S, BLI614223S, BLI612965S, BLI614470S, BLI614328S, BLI612930S, BLI614745S, BLI613327S, BLI613644S, BLI614143S, BLI614572S, BLI613706S, BLI613721S, BLI612702S, BLI612763S, BLI612846S, BLI614229S, BLI614461S, BLI613447S, BLI614006S, BLI613297S, BLI613443S, BLI613697S, BLI614181S, BLI613732S, BLI612759S, BLI613453S, BLI613714S, BLI614305S, BLI614481S, BLI614601S, BLI613877S, BLI613405S, BLI614475S, BLI614145S, BLI612817S, BLI613782S, BLI614032S, BLI614466S, BLI612730S, BLI614177S, BLI614763S, BLI613445S, BLI613774S, BLI613315S, BLI614313S, BLI613783S, BLI614320S, BLI612845S, BLI613369S, BLI612723S, BLI612835S, BLI613866S, BLI613220S, BLI613226S, BLI613254S, BLI614001S, BLI613323S, BLI613281S, BLI614220S, BLI613878S, BLI612464S, BLI614216S, BLI612715S, BLI612785S, BLI614322S, BLI612842S, BLI614146S, BLI614735S, BLI613236S, BLI612664S, BLI612665S, BLI613273S, BLI613282S, BLI613450S, BLI612751S, BLI613657S, BLI613996S, BLI613719S, BLI614734S, BLI614046S, BLI614752S, BLI614792S, BLI612936S, BLI613253S, BLI614315S, BLI614813S, BLI612573S, BLI612865S, BLI612799S, BLI614155S, BLI614198S, BLI614226S, BLI612766S, BLI612695S, BLI612815S, BLI614299S, BLI614471S, BLI614987S, BLI615026S, BLI614327S, BLI613872S, BLI612792S, BLI614497S, BLI613301S, BLI614208S, BLI614571S, BLI613596S, BLI612701S, BLI612830S, BLI612931S, BLI613291S, BLI613487S, BLI613672S, BLI613762S, BLI614726S, BLI612667S, BLI612669S, BLI612670S, BLI612708S, BLI612710S, BLI612806S, BLI612807S, BLI613227S, BLI614158S, BLI614717S, BLI614783S, BLI612912S, BLI614833S, BLI612658S, BLI612834S, BLI613319S, BLI613289S, BLI613676S, BLI614793S, BLI613333S, BLI614329S, BLI614476S, BLI613306S, BLI614835S, BLI614310S, BLI613600S, BLI614148S, BLI614483S, BLI612716S, BLI613302S, BLI613484S, BLI613720S, BLI613742S, BLI614004S, BLI613414S, BLI614092S, BLI613466S, BLI613278S, BLI614484S, BLI614727S, BLI614035S, BLI614596S, BLI614293S, BLI614319S, BLI614324S, BLI612852S, BLI613862S, BLI613311S, BLI613318S, BLI613320S, BLI613338S, BLI613339S, BLI613340S, BLI614597S, BLI613562S, BLI614008S, BLI614740S, BLI614785S, BLI612724S, BLI613285S, BLI612904S, BLI612910S, BLI614832S, BLI612944S, BLI614464S, BLI613367S, BLI612933S, BLI614015S, BLI613257S, BLI613288S, BLI612827S, BLI614777S, BLI613286S, BLI613464S; GTIN 00643169720282, Lot Serial Numbers: BLI613497S, BLI612633S, BLI612639S, BLI612814S, BLI612816S, BLI612818S, BLI612474S, BLI612565S, BLI612624S, BLI613054S, BLI613064S, BLI612544S, BLI613408S, BLI613062S, BLI613365S, BLI613542S, BLI613547S, BLI612618S, BLI613363S, BLI612562S, BLI613069S, BLI613083S, BLI613530S, BLI613725S, BLI613410S, BLI613548S, BLI613559S, BLI612513S, BLI612663S, BLI612541S, BLI612550S, BLI613082S, BLI613072S, BLI613074S, BLI613075S, BLI612712S, BLI612713S, BLI612450S, BLI612469S, BLI612509S, BLI612171S, BLI612496S, BLI612534S, BLI612482S, BLI612484S, BLI612490S, BLI612580S, BLI613353S, BLI613376S, BLI613057S, BLI612630S, BLI612641S, BLI612645S, BLI612696S, BLI612697S, BLI612455S, BLI612756S, BLI612634S, BLI612637S, BLI613090S, BLI613535S, BLI612542S, BLI613539S, BLI613372S, BLI612540S, BLI613055S, BLI612449S, BLI612685S, BLI613079S, BLI613081S, BLI612552S, BLI612564S, BLI612546S, BLI612561S, BLI613080S, BLI613108S, BLI613529S, BLI614756S, BLI612654S, BLI613375S, BLI613105S, BLI613126S, BLI613127S, BLI613133S, BLI613136S, BLI613140S, BLI612533S, BLI612535S, BLI613825S, BLI614725S, BLI612860S, BLI612563S, BLI612673S, BLI613109S, BLI613110S, BLI613111S, BLI613112S, BLI612553S, BLI613374S, BLI613039S, BLI613685S, BLI613709S, BLI612591S, BLI613183S, BLI613188S, BLI613448S, BLI613659S, BLI613710S, BLI613760S, BLI613797S, BLI614080S, BLI614104S, BLI612593S, BLI612629S, BLI612761S, BLI613016S, BLI613139S, BLI613145S, BLI613456S, BLI613463S, BLI613698S, BLI612589S, BLI612647S, BLI612760S, BLI612784S, BLI613121S, BLI613134S, BLI613156S, BLI613185S, BLI613196S, BLI612789S, BLI613195S, BLI613651S, BLI613690S, BLI613715S, BLI613769S, BLI613791S, BLI614206S, BLI612622S, BLI613162S, BLI614090S, BLI613168S, BLI613170S, BLI613171S, BLI613172S, BLI613175S, BLI612608S, BLI612613S, BLI612614S, BLI612642S, BLI612666S, BLI613071S, BLI613129S, BLI613130S, BLI613135S, BLI613142S, BLI613147S, BLI613191S, BLI613213S, BLI613477S, BLI613646S, BLI613679S, BLI613683S, BLI614086S, BLI614204S, BLI614211S, BLI612612S, BLI613144S, BLI614072S, BLI614085S, BLI614107S, BLI612660S, BLI612770S, BLI613692S, BLI612812S, BLI613076S, BLI613163S, BLI613470S, BLI614207S, BLI612775S, BLI613190S, BLI612765S, BLI612810S, BLI613041S, BLI613053S, BLI613192S, BLI613444S, BLI613471S, BLI613648S, BLI614071S, BLI612598S, BLI612662S, BLI612750S, BLI612811S, BLI613017S, BLI613157S, BLI613197S, BLI613199S, BLI613201S, BLI613206S, BLI612518S, BLI612604S, BLI612672S, BLI612788S, BLI612793S, BLI613066S, BLI613131S, BLI613141S, BLI613184S, BLI613207S, BLI613647S, BLI613688S, BLI614094S, BLI614105S, BLI614213S, BLI614214S, BLI612605S, BLI612638S, BLI613148S, BLI613149S, BLI613150S, BLI613187S, BLI613193S, BLI613482S, BLI613668S, BLI613670S, BLI613777S, BLI613778S, BLI613780S, BLI614089S, BLI613128S, BLI613146S, BLI613210S, BLI613478S, BLI612577S, BLI612626S, BLI612671S, BLI613158S, BLI613161S, BLI613180S, BLI613469S, BLI613479S, BLI613480S, BLI613708S, BLI612640S, BLI613092S, BLI612651S, BLI612809S, BLI613409S, BLI613411S, BLI613540S, BLI612458S, BLI612460S, BLI612683S, BLI613078S, BLI612690S, BLI612536S, BLI612538S, BLI612539S, BLI612547S, BLI612668S, BLI613392S, BLI613645S, BLI613988S, BLI613391S, BLI613390S, BLI613246S, BLI612729S, BLI612740S, BLI612742S, BLI612747S, BLI612863S, BLI612864S, BLI612875S, BLI612915S, BLI612924S, BLI612927S, BLI612929S, BLI612932S, BLI612986S, BLI612987S, BLI612992S, BLI612993S, BLI613000S, BLI613001S, BLI613004S, BLI613005S, BLI613006S, BLI613014S, BLI613018S, BLI613020S, BLI613022S, BLI613023S, BLI613024S, BLI613025S, BLI613027S, BLI613028S, BLI613031S, BLI613035S, BLI613557S, BLI613582S, BLI613583S, BLI613584S, BLI613585S, BLI613587S, BLI613755S, BLI613756S, BLI613820S, BLI613821S, BLI613822S, BLI613823S, BLI613824S, BLI613826S, BLI613827S, BLI613828S, BLI613835S, BLI614033S, BLI614034S, BLI614037S, BLI614079S, BLI614150S, BLI614151S, BLI614152S, BLI614172S, BLI614176S, BLI614183S, BLI614185S, BLI614186S, BLI614212S, BLI614231S, BLI614232S, BLI614273S, BLI614275S, BLI614276S, BLI614278S, BLI614280S, BLI614281S, BLI614282S, BLI614283S, BLI613563S, BLI612503S, BLI613056S, BLI612493S, BLI612519S, BLI612728S, BLI612746S, BLI612895S, BLI613599S, BLI613752S, BLI613837S, BLI613935S, BLI613936S, BLI613947S, BLI613971S, BLI613977S, BLI613983S, BLI613984S, BLI613985S, BLI613986S, BLI614023S, BLI614026S, BLI614096S, BLI614098S, BLI614099S, BLI613061S, BLI613526S, BLI612578S, BLI613059S, BLI613070S, BLI613329S, BLI613337S, BLI613527S, BLI612571S, BLI613342S, BLI612555S, BLI612454S, BLI614720S, BLI612559S, BLI612557S, BLI613341S, BLI613322S, BLI612798S, BLI612988S, BLI612609S, BLI613382S, BLI612486S, BLI612506S, BLI612507S, BLI612508S, BLI612510S, BLI612583S, BLI612592S, BLI612602S, BLI612607S, BLI612625S, BLI612779S, BLI612782S, BLI612786S, BLI612819S, BLI612820S, BLI612822S, BLI612844S, BLI612848S, BLI612849S, BLI612851S, BLI612891S, BLI612928S, BLI613040S, BLI613042S, BLI613043S, BLI613044S, BLI613118S, BLI613119S, BLI613120S, BLI613122S, BLI613123S, BLI613124S, BLI613125S, BLI613132S, BLI613137S, BLI613173S, BLI613174S, BLI613176S, BLI613177S, BLI613194S, BLI613310S, BLI613317S, BLI613321S, BLI613389S, BLI613458S, BLI613459S, BLI613460S, BLI613475S, BLI613495S, BLI613618S, BLI613619S, BLI613620S, BLI613621S, BLI613622S, BLI612777S, BLI612524S, BLI612525S, BLI613036S, BLI613474S,... |
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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.