Recall archive / FDA device enforcement
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators — FDA record Z-1751-2023
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 DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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
- 1754 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1751-2023
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 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY602563S, BLY602693S, BLY602474S, BLY602424S, BLY602465S, BLY602812S, BLY602676S, BLY602445S, BLY602572S, BLY602497S, BLY602549S, BLY602715S, BLY602735S, BLY602531S, BLY602657S, BLY603005S, BLY602489S, BLY602628S, BLY602652S, BLY602459S, BLY602483S, BLY602576S, BLY602450S, BLY602521S, BLY602574S, BLY602680S, BLY602386S, BLY602463S, BLY602694S, BLY602747S, BLY602449S, BLY602401S, BLY602413S, BLY602432S, BLY602631S, BLY602633S, BLY602672S, BLY602740S, BLY602741S, BLY602403S, BLY602412S, BLY602517S, BLY602528S, BLY602430S, BLY602501S, BLY602270S, BLY602552S, BLY602713S, BLY602478S, BLY602543S, BLY602443S, BLY602464S, BLY602634S, BLY602421S, BLY602564S, BLY602462S, BLY602525S, BLY602673S, BLY602717S, BLY602734S, BLY602467S, BLY602487S, BLY602377S, BLY602682S, BLY602712S, BLY602423S, BLY602659S, BLY602725S, BLY602393S, BLY602524S, BLY602565S, BLY602630S, BLY602378S, BLY602696S, BLY602438S, BLY602475S, BLY602653S, BLY602711S, BLY602661S, BLY602539S, BLY602533S, BLY602558S, BLY602561S, BLY602675S, BLY602534S, BLY602499S, BLY602814S, BLY602368S, BLY602437S, BLY602727S, BLY602435S, BLY602444S, BLY602530S, BLY602688S, BLY602470S, BLY602658S, BLY602453S, BLY602454S, BLY602507S, BLY602555S, BLY602405S, BLY602729S, BLY602477S, BLY602258S, BLY602473S, BLY602720S, BLY602815S, BLY602829S, BLY602833S, BLY602835S, BLY602839S, BLY603060S, BLY602508S, BLY602371S, BLY602388S, BLY602724S, BLY602383S, BLY602529S, BLY602502S, BLY602730S, BLY603004S, BLY602485S, BLY602472S, BLY602484S, BLY602366S, BLY602415S, BLY602427S, BLY602495S, BLY602738S, BLY602406S, BLY602515S, BLY602367S, BLY602420S, BLY602436S, BLY602569S, BLY602455S, BLY602684S, BLY602387S, BLY602398S, BLY602660S, BLY602567S, BLY602433S, BLY602666S, BLY602723S, BLY602494S, BLY602677S, BLY602678S, BLY602679S, BLY602510S, BLY602523S, BLY602687S, BLY602568S, BLY602498S, BLY602671S, BLY602522S, BLY602746S, BLY602506S, BLY602545S, BLY602400S, BLY602664S, BLY602665S, BLY602697S, BLY602513S, BLY602461S, BLY602379S, BLY602670S, BLY602559S, BLY602481S, BLY602442S, BLY602380S, BLY602417S, BLY602418S, BLY602429S, BLY602538S, BLY602686S, BLY602369S, BLY602419S, BLY602399S, BLY602425S, BLY602509S, BLY602542S, BLY602683S, BLY602370S, BLY602505S, BLY602535S, BLY602541S, BLY602654S, BLY602381S, BLY602492S, BLY602722S, BLY602408S, BLY602363S, BLY602426S, BLY602860S, BLY602503S, BLY602466S, BLY602460S, BLY602619S, BLY602439S, BLY602516S, BLY602623S, BLY602624S, BLY602721S, BLY602737S, BLY602486S, BLY602669S, BLY602731S, BLY602690S, BLY602259S, BLY602362S, BLY602457S, BLY602490S, BLY602374S, BLY602375S, BLY602662S, BLY602728S, BLY602691S, BLY602361S, BLY602456S, BLY602578S, BLY602603S, BLY602644S, BLY602645S, BLY602646S, BLY602422S, BLY602397S, BLY602585S, BLY602592S, BLY602596S, BLY602597S, BLY602607S, BLY602620S, BLY602622S, BLY602625S, BLY602632S, BLY602651S, BLY602667S, BLY602689S, BLY602816S, BLY602831S, BLY602874S, BLY602876S, BLY602980S, BLY602981S, BLY603191S, BLY603194S, BLY603204S, BLY603205S, BLY603208S, BLY602385S, BLY602580S, BLY602583S, BLY602584S, BLY602588S, BLY602589S, BLY602599S, BLY602605S, BLY602609S, BLY602612S, BLY602647S, BLY602648S, BLY602810S, BLY602819S, BLY602832S, BLY602871S, BLY602879S, BLY602985S, BLY602988S, BLY602989S, BLY602991S, BLY602995S, BLY603007S, BLY603054S, BLY603062S, BLY603065S, BLY603068S, BLY603203S, BLY602394S, BLY602570S, BLY602595S, BLY602600S, BLY602604S, BLY602608S, BLY602610S, BLY602614S, BLY602617S, BLY602650S, BLY602748S, BLY602873S, BLY602875S, BLY602983S, BLY602984S, BLY602986S, BLY602992S, BLY602993S, BLY602996S, BLY602997S, BLY602998S, BLY602999S, BLY603049S, BLY603057S, BLY603058S, BLY603059S, BLY603061S, BLY603064S, BLY603067S, BLY603189S, BLY603192S, BLY603193S, BLY603196S, BLY603198S, BLY603199S, BLY603200S, BLY603202S, BLY603008S, BLY602518S, BLY602627S, BLY602719S, BLY602476S, BLY602598S, BLY602602S, BLY602618S, BLY602744S, BLY602745S, BLY602594S, BLY602838S, BLY602573S, BLY602581S, BLY602591S, BLY602837S, BLY602613S, BLY602616S, BLY602577S, BLY602586S, BLY602382S, BLY602404S, BLY602451S, BLY603001S, BLY602395S, BLY602990S, BLY603002S, BLY602655S, BLY602488S, BLY602504S, BLY602742S, BLY602527S, BLY602550S, BLY602733S, BLY602411S, BLY602440S, BLY602448S, BLY602471S, BLY602540S, BLY602364S, BLY602365S, BLY602500S, BLY602520S, BLY602695S, BLY602469S, BLY602410S, BLY602491S, BLY602571S, BLY602732S, BLY602396S, BLY602587S, BLY602601S, BLY602606S, BLY602611S, BLY602629S, BLY602749S, BLY602877S, BLY602878S, BLY602880S, BLY602982S, BLY602987S, BLY602994S, BLY603050S, BLY603056S, BLY603066S, BLY603190S, BLY603201S, BLY603206S, BLY603207S, BLY602479S, BLY602480S, BLY602656S, BLY602376S, BLY602590S, BLY602621S, BLY602626S, BLY602811S, BLY602817S, BLY602818S, BLY602872S, BLY603051S, BLY603055S, BLY603195S, BLY603197S, BLY603000S; GTIN 00643169980198, Lot Serial Numbers: BLY604417S, BLY603039S, BLY603408S, BLY603693S, BLY604021S, BLY604048S, BLY604373S, BLY603363S, BLY603646S, BLY603660S, BLY603917S, BLY604062S, BLY604210S, BLY603834S, BLY604045S, BLY603409S, BLY602787S, BLY602946S, BLY604029S, BLY604226S, BLY603599S, BLY604103S, BLY603419S, BLY603175S, BLY603428S, BLY603657S, BLY602776S, BLY602935S, BLY603848S, BLY604049S, BLY603829S, BLY603939S, BLY604187S, BLY603598S, BLY603434S, BLY603875S, BLY603978S, BLY604044S, BLY602760S, BLY602948S, BLY603438S, BLY603611S, BLY603720S, BLY603048S, BLY603256S, BLY603566S, BLY602855S, BLY602920S, BLY602958S, BLY603269S, BLY603351S, BLY603262S, BLY603457S, BLY602858S, BLY602941S, BLY602966S, BLY603114S, BLY603581S, BLY602799S, BLY603146S, BLY603478S, BLY603810S, BLY603862S, BLY603042S, BLY603650S, BLY603813S, BLY603033S, BLY603397S, BLY602767S, BLY603877S, BLY603311S, BLY603600S, BLY604052S, BLY604389S, BLY602857S, BLY603576S, BLY604014S, BLY604015S, BLY604363S, BLY604376S, BLY603622S, BLY603643S, BLY603661S, BLY603716S, BLY603744S, BLY602789S, BLY603072S, BLY603314S, BLY604275S, BLY604331S, BLY604339S, BLY603570S, BLY603591S, BLY603849S, BLY603874S, BLY604013S, BLY604292S, BLY604335S, BLY604105S, BLY604276S, BLY604408S, BLY602913S, BLY602926S, BLY603043S, BLY603047S, BLY603082S, BLY603333S, BLY603388S, BLY603421S, BLY603442S, BLY603455S, BLY603567S, BLY603653S, BLY603844S, BLY604158S, BLY604106S, BLY602978S, BLY603250S, BLY603264S, BLY603443S, BLY603554S, BLY603745S, BLY603882S, BLY604024S, BLY604037S, BLY604097S, BLY604214S, BLY604235S, BLY604283S, BLY604287S, BLY604384S, BLY604385S, BLY603139S, BLY603385S, BLY603400S, BLY604036S, BLY604237S, BLY604238S, BLY603305S, BLY603306S, BLY603307S, BLY603308S, BLY603687S, BLY603827S, BLY603901S, BLY603972S, BLY604186S, BLY604378S, BLY604003S, BLY603483S, BLY603561S, BLY603931S, BLY603731S, BLY604183S, BLY602911S, BLY603377S, BLY603464S, BLY604040S, BLY604294S, BLY604085S, BLY603574S, BLY603878S, BLY604341S, BLY604349S, BLY604350S, BLY604197S, BLY604344S, BLY604351S, BLY604159S, BLY604326S, BLY604446S, BLY604447S, BLY603658S, BLY603659S, BLY603717S, BLY603982S, BLY603983S, BLY604086S, BLY604163S, BLY604164S, BLY604189S, BLY604299S, BLY604300S, BLY604312S, BLY604333S, BLY604342S, BLY604359S, BLY603225S, BLY603572S, BLY603833S, BLY603859S, BLY604054S, BLY604449S, BLY603477S, BLY603606S, BLY604362S, BLY604392S, BLY602844S, BLY602845S, BLY602886S, BLY602927S, BLY602965S, BLY603083S, BLY603244S, BLY603742S, BLY603807S, BLY603896S, BLY603956S, BLY603957S, BLY604213S, BLY604231S, BLY604347S, BLY604361S, BLY604379S, BLY604380S, BLY604382S, BLY604396S, BLY602821S, BLY602822S, BLY602823S, BLY602892S, BLY602893S, BLY602972S, BLY602974S, BLY603117S, BLY603181S, BLY603182S, BLY603316S, BLY603390S, BLY603393S, BLY603507S, BLY603510S, BLY603603S, BLY603604S, BLY603676S, BLY603739S, BLY603782S, BLY603817S, BLY604198S, BLY604243S, BLY604284S, BLY604329S, BLY604334S, BLY604358S, BLY604366S, BLY604381S, BLY604397S, BLY604407S, BLY604434S, BLY602903S, BLY603037S, BLY603088S, BLY603127S, BLY603140S, BLY603282S, BLY603330S, BLY604340S, BLY603358S, BLY603239S, BLY604196S, BLY603271S, BLY603610S, BLY603303S, BLY602852S, BLY603129S, BLY603212S, BLY603528S, BLY603555S, BLY603673S, BLY604150S, BLY604303S, BLY603615S, BLY602883S, BLY602930S, BLY602940S, BLY603045S, BLY603156S, BLY603210S, BLY603213S, BLY603245S, BLY603259S, BLY603309S, BLY603342S, BLY603365S, BLY603366S, BLY603404S, BLY603471S, BLY603482S, BLY603485S, BLY603500S, BLY603624S, BLY603631S, BLY603655S, BLY603668S, BLY603684S, BLY603793S, BLY603812S, BLY603815S, BLY603897S, BLY603923S, BLY603925S, BLY603927S, BLY603941S, BLY603992S, BLY604004S, BLY604060S, BLY604063S, BLY604070S, BLY604077S, BLY604088S, BLY604111S, BLY604115S, BLY604132S, BLY604148S, BLY604149S, BLY604193S, BLY604215S, BLY604295S, BLY604310S, BLY604311S, BLY603626S, BLY603803S, BLY603868S, BLY603317S, BLY603585S, BLY603617S, BLY603789S, BLY603965S, BLY603030S, BLY602751S, BLY602904S, BLY602917S, BLY603277S, BLY603459S, BLY603632S, BLY603756S, BLY603898S, BLY603960S, BLY604031S, BLY603019S, BLY603240S, BLY603450S, BLY602916S, BLY603125S, BLY603149S, BLY603158S, BLY603166S, BLY603437S, BLY603662S, BLY603734S, BLY603943S, BLY604023S, BLY604108S, BLY604140S, BLY604203S, BLY603706S, BLY602902S, BLY604025S, BLY603180S, BLY603616S, BLY602901S, BLY602919S, BLY602960S, BLY603211S, BLY603420S, BLY603533S, BLY603719S, BLY603984S, BLY603099S, BLY603414S, BLY603417S, BLY602848S, BLY603299S, BLY603642S, BLY602842S, BLY603364S, BLY604011S, BLY604234S, BLY603552S, BLY603768S, BLY604233S, BLY602774S, BLY603806S, BLY603808S, BLY602953S, BLY604141S, BLY604142S, BLY604143S, BLY604145S, BLY604146S, BLY602755S, BLY602905S, BLY603089S, BLY603109S, BLY603275S, BLY603302S, BLY603391S, BLY603394S, BLY603497S, BLY603502S, BLY603584S, BLY603743S, BLY603746S, BLY603748S, BLY603241S, BLY603273S, BLY603964S, BLY603970S, BLY604093S, BLY604170S, BLY603350S, BLY603860S, BLY602895S, BLY603670S, BLY604082S, BLY603908S, BLY602756S, BLY602971S, BLY603551S, BLY603819S, BLY602761S, BLY603785S, BLY604169S, BLY604291S, BLY604330S, BLY603069S, BLY603251S, BLY603529S, BLY603824S, BLY602764S, BLY603070S, BLY603097S, BLY603164S, BLY603263S, BLY603889S, BLY603890S, BLY603280S, BLY603398S, BLY603559S, BLY604094S, BLY602805S, BLY603628S, BLY602922S, BLY603041S, BLY603484S, BLY603499S, BLY603550S, BLY603635S, BLY603854S, BLY604119S, BLY603766S, BLY603767S, BLY603119S, BLY603134S, BLY603287S, BLY603462S, BLY603504S, BLY604050S, BLY604079S, BLY603040S, BLY603144S, BLY602775S, BLY603084S, BLY603087S, BLY603227S, BLY603080S, BLY603609S, BLY603416S, BLY603432S, BLY603248S, BLY602849S, BLY602884S, BLY603418S, BLY603461S, BLY603546S, BLY603688S, BLY603077S, BLY602933S, BLY603035S, BLY603036S, BLY603236S, BLY603380S, BLY603579S, BLY604096S, BLY602752S, BLY602758S, BLY602765S, BLY602781S, BLY602783S, BLY602949S, BLY603071S, BLY603094S, BLY603260S, BLY603078S, BLY604188S, BLY602961S, BLY603115S, BLY603517S, BLY603769S, BLY603914S, BLY602939S, BLY604178S, BLY602951S, BLY603110S, BLY603608S, BLY603715S, BLY603467S, BLY603178S, BLY603740S, BLY602945S, BLY602952S, BLY603153S, BLY603161S, BLY603300S, BLY603458S, BLY603754S, BLY603764S, BLY603997S, BLY603998S, BLY604304S, BLY603231S, BLY603989S, BLY604001S, BLY604281S, BLY602897S, BLY602898S, BLY603752S, BLY603841S, BLY602826S, BLY603469S, BLY603475S, BLY603695S, BLY603863S, BLY603926S, BLY604046S, BLY603124S, BLY603313S, BLY603373S, BLY603383S, BLY603685S, BLY603784S, BLY603894S, BLY603909S, BLY603952S, BLY604005S, BLY604058S, BLY604110S, BLY604191S, BLY603543S, BLY602788S, BLY603621S, BLY603647S, BLY603961S, BLY603991S, BLY602782S, BLY602929S, BLY602932S, BLY602954S, BLY603249S, BLY603912S, BLY603942S, BLY603955S, BLY603014S, BLY603654S, BLY603913S, BLY603966S, BLY604151S, BLY604267S, BLY602791S, BLY603023S, BLY603142S, BLY603732S, BLY602792S, BLY602809S, BLY602885S, BLY602907S, BLY603013S, BLY603185S, BLY603229S, BLY603395S, BLY603405S, BLY603436S, BLY603496S, BLY603538S, BLY603633S, BLY603694S, BLY603781S, BLY603797S,... |
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.