CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrilla...
FDA Device Recall #Z-1733-2023 — Class I — May 10, 2023
Recall Summary
| Recall Number | Z-1733-2023 |
| Classification | Class I — Serious risk |
| Date Initiated | May 10, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Location | Mounds View, MN |
| Product Type | Devices |
| Quantity | 891 units |
Product Description
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
Reason for Recall
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.
Distribution Pattern
US Nationwide - Worldwide Distribution
Lot / Code Information
GTIN 00643169720138, Lot Serial Numbers: BLC228471H, BLC228476H, BLC228533H, BLC228541H, BLC228635H, BLC228702H, BLC228745H, BLC228827H, BLC228830H, BLC228840H, BLC228872H, BLC227820H, BLC228658H, BLC228889H, BLC228890H, BLC228895H, BLC228896H, BLC228900H, BLC228350H, BLC228567H, BLC228738H, BLC229053H, BLC229197H, BLC229064H, BLC228295H, BLC228587H, BLC228382H, BLC228585H, BLC228296H, BLC228583H, BLC228787H, BLC228926H, BLC229106H, BLC228579H, BLC228245H, BLC228551H, BLC228625H, BLC228819H, BLC228440H, BLC228622H, BLC228825H, BLC228456H, BLC228432H, BLC228960H, BLC229166H, BLC228545H, BLC228676H, BLC228695H, BLC228573H, BLC229089H, BLC228721H, BLC228898H, BLC228980H, BLC229099H, BLC228302H, BLC228256H, BLC228258H, BLC228300H, BLC228319H, BLC228355H, BLC228394H, BLC228406H, BLC228450H, BLC228461H, BLC228515H, BLC228309H, BLC228379H, BLC228491H, BLC228510H, BLC228511H, BLC228577H, BLC228707H, BLC228800H, BLC228861H, BLC229110H, BLC229192H, BLC229207H, BLC229107H, BLC228228H, BLC228312H, BLC229032H, BLC229062H, BLC229094H, BLC229161H, BLC229169H, BLC229210H, BLC228653H, BLC228685H, BLC228409H, BLC229144H, BLC228581H, BLC228940H, BLC229154H, BLC228580H, BLC228509H, BLC228593H, BLC228614H, BLC229219H, BLC228386H, BLC228466H, BLC228810H, BLC228235H, BLC228428H, BLC228462H, BLC228463H, BLC228464H, BLC228470H, BLC228485H, BLC228488H, BLC228492H, BLC228493H, BLC228495H, BLC228497H, BLC228502H, BLC228504H, BLC228508H, BLC228985H, BLC228986H, BLC228987H, BLC228999H, BLC229000H, BLC229001H, BLC229003H, BLC229131H, BLC229132H, BLC229133H, BLC229212H, BLC228970H, BLC228641H, BLC228769H, BLC228324H, BLC228562H, BLC228610H, BLC228619H, BLC228505H, BLC228547H, BLC228589H, BLC228469H, BLC228559H, BLC228571H, BLC228774H, BLC228977H, BLC228984H, BLC229088H, BLC229093H, BLC229111H, BLC229191H, BLC229100H, BLC228403H, BLC228483H, BLC228399H, BLC228402H, BLC228768H, BLC228942H, BLC228574H, BLC228842H, BLC228538H, BLC228568H, BLC228906H, BLC229118H, BLC228654H, BLC229123H, BLC228250H, BLC228305H, BLC228348H, BLC228396H, BLC228475H, BLC228503H, BLC228566H, BLC228592H, BLC228965H, BLC228976H, BLC229033H, BLC228356H, BLC228482H, BLC228916H, BLC229036H, BLC228365H, BLC228546H, BLC228272H, BLC228273H, BLC228276H, BLC228280H, BLC228289H, BLC228290H, BLC228307H, BLC228338H, BLC228354H, BLC228359H, BLC228367H, BLC228368H, BLC228417H, BLC228420H, BLC228427H, BLC228444H, BLC228452H, BLC228467H, BLC228486H, BLC228501H, BLC228523H, BLC228525H, BLC228526H, BLC228532H, BLC228536H, BLC228550H, BLC228555H, BLC228611H, BLC228627H, BLC228876H, BLC228882H, BLC228884H, BLC228901H, BLC228911H, BLC228928H, BLC228935H, BLC228958H, BLC228963H, BLC228967H, BLC228969H, BLC228990H, BLC228991H, BLC228992H, BLC229002H, BLC229006H, BLC229007H, BLC229019H, BLC229023H, BLC229027H, BLC229030H, BLC229048H, BLC229049H, BLC229050H, BLC229055H, BLC229056H, BLC229079H, BLC229084H, BLC229113H, BLC229136H, BLC229137H, BLC229138H, BLC229139H, BLC229140H, BLC229141H, BLC229146H, BLC229152H, BLC229163H, BLC229167H, BLC229171H, BLC229173H, BLC229174H, BLC229175H, BLC228982H, BLC228448H, BLC228293H, BLC228794H, BLC228468H, BLC228252H, BLC228457H, BLC228487H, BLC228724H, BLC228939H, BLC228952H, BLC228836H, BLC228938H, BLC228972H, BLC228242H, BLC228292H, BLC228287H, BLC228374H, BLC228288H, BLC228291H, BLC228378H, BLC228398H, BLC228643H, BLC228795H, BLC228943H, BLC229195H, BLC228282H, BLC228500H, BLC228244H, BLC228656H, BLC228357H, BLC229129H, BLC228408H, BLC228405H, BLC228788H, BLC228313H, BLC228322H, BLC228517H, BLC228650H, BLC228848H, BLC228308H, BLC228347H, BLC228426H, BLC228480H, BLC228781H, BLC228905H, BLC228918H, BLC228921H, BLC229061H, BLC229087H, BLC229102H, BLC229157H, BLC229200H, BLC228799H, BLC228460H, BLC229156H, BLC228237H, BLC228316H, BLC228419H, BLC228596H, BLC228662H, BLC228779H, BLC228885H, BLC228902H, BLC229017H, BLC229120H, BLC229189H, BLC228598H, BLC228311H, BLC228436H, BLC228703H, BLC228973H, BLC228337H, BLC228220H, BLC228221H, BLC228223H, BLC228232H, BLC228241H, BLC228342H, BLC228344H, BLC228369H, BLC228375H, BLC228425H, BLC228496H, BLC228597H, BLC228639H, BLC228655H, BLC228663H, BLC228664H, BLC228671H, BLC228679H, BLC228688H, BLC228722H, BLC228730H, BLC228734H, BLC228736H, BLC228750H, BLC228786H, BLC228790H, BLC228829H, BLC228833H, BLC228880H, BLC228893H, BLC228897H, BLC228927H, BLC228931H, BLC228947H, BLC228981H, BLC228983H, BLC229016H, BLC229039H, BLC229072H, BLC229075H, BLC229109H, BLC229119H, BLC229121H, BLC229125H, BLC229177H, BLC229181H, BLC229182H, BLC229183H, BLC229185H, BLC229190H, BLC229215H, BLC228339H, BLC228857H, BLC228681H, BLC228692H, BLC228783H, BLC228849H, BLC228878H, BLC228924H, BLC228998H, BLC229127H, BLC229128H, BLC228543H, BLC228404H, BLC228412H, BLC228439H, BLC228797H, BLC228397H, BLC228629H, BLC228372H, BLC228773H, BLC228804H, BLC228844H, BLC229040H, BLC229186H, BLC229209H, BLC228243H, BLC229005H, BLC228303H, BLC229198H, BLC228340H, BLC228859H, BLC228767H, BLC228771H, BLC228263H, BLC228315H, BLC228780H, BLC228920H, BLC229057H, BLC228601H, BLC228666H, BLC229025H, BLC229208H, BLC228754H, BLC228764H, BLC228775H, BLC228363H, BLC228520H, BLC228549H, BLC228254H, BLC228331H, BLC228361H, BLC228381H, BLC228385H, BLC228392H, BLC228431H, BLC228442H, BLC228447H, BLC228473H, BLC228518H, BLC228831H, BLC228837H, BLC228936H, BLC228953H, BLC228978H, BLC229024H, BLC229026H, BLC229029H, BLC229073H, BLC229104H, BLC229105H, BLC229126H, BLC228529H, BLC229020H, BLC228974H, BLC228270H, BLC228225H, BLC228285H, BLC228539H, BLC228684H, BLC229058H, BLC228326H, BLC228294H, BLC228366H, BLC228766H, BLC229037H, BLC228264H, BLC229067H, BLC229164H, BLC229165H, BLC228414H, BLC228494H, BLC228735H, BLC228752H, BLC228698H, BLC228332H, BLC228633H, BLC228472H, BLC229012H, BLC228455H, BLC229015H, BLC228384H, BLC228423H, BLC228219H, BLC228306H, BLC228560H, BLC228803H, BLC228881H, BLC229060H, BLC229078H, BLC229148H, BLC228677H, BLC229115H, BLC228335H, BLC228346H, BLC228362H, BLC229202H, BLC228253H, BLC228327H, BLC228336H, BLC228380H, BLC228535H, BLC228807H, BLC228565H, BLC228602H, BLC228534H, BLC228605H, BLC228620H, BLC228913H, BLC228310H, BLC228675H, BLC229081H, BLC228323H, BLC228563H, BLC228572H, BLC228624H, BLC228682H, BLC228867H, BLC229066H, BLC228856H, BLC228661H, BLC228556H, BLC228226H, BLC228238H, BLC228259H, BLC228318H, BLC228659H, BLC228922H, BLC228343H, BLC228513H, BLC228360H, BLC228820H, BLC228957H, BLC228320H, BLC228341H, BLC228358H, BLC228370H, BLC228443H, BLC228808H, BLC228817H, BLC228847H, BLC228888H, BLC228891H, BLC228894H, BLC229091H, BLC229092H, BLC229096H, BLC228389H, BLC228373H, BLC228376H, BLC228388H, BLC228391H, BLC228489H, BLC228521H, BLC228704H, BLC229193H, BLC228989H, BLC228979H, BLC229022H, BLC229179H, BLC228234H, BLC228383H, BLC228558H, BLC228613H, BLC228945H, BLC228770H, BLC228785H, BLC228877H, BLC229135H, BLC229159H, BLC229160H, BLC229097H, BLC228255H, BLC228371H, BLC228422H, BLC228430H, BLC228433H, BLC228437H, BLC228441H, BLC228465H, BLC228474H, BLC228484H, BLC228530H, BLC228557H, BLC228588H, BLC228595H, BLC228616H, BLC228632H, BLC228645H, BLC228649H, BLC228651H, BLC228660H, BLC228689H, BLC228691H, BLC228696H, BLC228740H, BLC228762H, BLC228802H, BLC228846H, BLC228908H, BLC228949H, BLC228956H, BLC228961H, BLC228962H, BLC229035H, BLC229051H, BLC229054H, BLC229069H, BLC229076H, BLC229077H, BLC229117H, BLC228353H, BLC228777H, BLC228951H, BLC228665H, BLC228865H, BLC228892H, BLC229122H, BLC228352H, BLC228544H, BLC228407H, BLC228490H, BLC228519H, BLC228791H, BLC228806H, BLC228838H, BLC228875H, BLC229031H, BLC229074H, BLC229080H, BLC229095H, BLC229151H, BLC229153H, BLC229155H, BLC229162H, BLC228638H, BLC228886H, BLC228907H, BLC229082H, BLC229206H, BLC228481H, BLC228553H, BLC228516H, BLC228959H, BLC228410H; GTIN 00763000059651, Lot Serial Numbers: BLC600191S, BLC600409S, BLC600416S, BLC600443S, BLC600449S, BLC600318S, BLC600054S, BLC600157S, BLC600175S, BLC600354S, BLC600482S, BLC600383S, BLC600533S, BLC600129S, BLC600062S, BLC600357S, BLC600433S, BLC600083S, BLC600505S, BLC600205S, BLC600479S, BLC600499S, BLC600060S, BLC600323S, BLC600372S, BLC600489S, BLC600085S, BLC600506S, BLC600081S, BLC600349S, BLC600199S, BLC600200S, BLC600437S, BLC600300S, BLC600182S, BLC600186S, BLC600311S, BLC600188S, BLC600467S, BLC600026S, BLC600185S, BLC600494S, BLC600140S, BLC600336S, BLC600469S, BLC600075S, BLC600355S, BLC600388S, BLC600305S, BLC600287S, BLC600405S, BLC600406S, BLC600037S, BLC600120S, BLC600353S, BLC600414S, BLC600448S, BLC600462S, BLC600445S, BLC600363S, BLC600162S, BLC600358S, BLC600099S, BLC600012S, BLC600013S, BLC600014S, BLC600015S, BLC600016S, BLC600018S, BLC600019S, BLC600234S, BLC600235S, BLC600236S, BLC600237S, BLC600238S, BLC600239S, BLC600240S, BLC600244S, BLC600246S, BLC600247S, BLC600248S, BLC600249S, BLC600251S, BLC600252S, BLC600407S, BLC600190S, BLC600153S, BLC600288S, BLC600206S, BLC600321S, BLC600420S, BLC600106S, BLC600315S, BLC600473S, BLC600478S, BLC600010S, BLC600097S, BLC600112S, BLC600150S, BLC600203S, BLC600293S, BLC600301S, BLC600463S, BLC600511S, BLC600306S, BLC600327S, BLC600328S, BLC600073S, BLC600281S, BLC600282S, BLC600285S, BLC600286S, BLC600394S, BLC600396S, BLC600404S, BLC600501S, BLC600513S, BLC600517S, BLC600283S, BLC600500S, BLC600028S, BLC600386S, BLC600453S, BLC600115S, BLC600295S, BLC600076S, BLC600397S, BLC600124S, BLC600077S, BLC600187S, BLC600024S, BLC600302S, BLC600457S, BLC600103S, BLC600068S, BLC600272S, BLC600411S, BLC600461S, BLC600029S, BLC600275S, BLC600046S, BLC600134S, BLC600034S, BLC600459S, BLC600346S, BLC600021S, BLC600419S, BLC600532S, BLC600148S, BLC600173S, BLC600470S, BLC600125S, BLC600198S, BLC600002S, BLC600089S, BLC600100S, BLC600166S, BLC600260S, BLC600360S, BLC600362S, BLC600384S, BLC600410S, BLC600418S, BLC600521S, BLC600522S, BLC600531S, BLC600233S, BLC600280S, BLC600389S, BLC600497S, BLC600387S, BLC600126S, BLC600197S, BLC600369S, BLC600474S, BLC600137S, BLC600436S, BLC600067S, BLC600277S, BLC600373S, BLC600033S, BLC600043S, BLC600165S, BLC600524S, BLC600483S, BLC600065S, BLC600507S, BLC600003S, BLC600004S, BLC600007S, BLC600008S, BLC600009S, BLC600109S, BLC600044S, BLC600087S, BLC600181S, BLC600289S, BLC600450S, BLC600534S, BLC600111S, BLC600154S, BLC600045S, BLC600110S, BLC600171S, BLC600465S, BLC600061S, BLC600366S, BLC600359S, BLC600456S, BLC600147S, BLC600343S, BLC600370S, BLC600485S, BLC600486S, BLC600487S, BLC600488S, BLC600138S, BLC600274S, BLC600298S, BLC600071S, BLC600128S, BLC600380S, BLC600415S, BLC600119S, BLC600139S, BLC600174S, BLC600212S, BLC600431S, BLC600095S, BLC600368S, BLC600036S, BLC600382S, BLC600096S, BLC600291S, BLC600267S, BLC600268S, BLC600269S, BLC600270S, BLC600515S, BLC600266S, BLC600452S, BLC600042S, BLC600155S, BLC600178S, BLC600341S, BLC600422S, BLC600518S, BLC600335S, BLC600365S, BLC600214S, BLC600468S, BLC600064S, BLC600184S, BLC600379S, BLC600093S, BLC600491S, BLC600527S, BLC600347S, BLC600529S, BLC600528S, BLC600439S, BLC600345S, BLC600116S, BLC600142S, BLC600271S, BLC600427S, BLC600292S, BLC600057S, BLC600385S, BLC600259S, BLC600451S, BLC600160S, BLC600164S, BLC600204S, BLC600421S, BLC600444S, BLC600454S, BLC600480S, BLC600504S, BLC600066S, BLC600464S, BLC600052S, BLC600101S, BLC600350S, BLC600378S, BLC600179S, BLC600352S, BLC600466S, BLC600192S, BLC600208S, BLC600209S, BLC600210S, BLC600211S, BLC600215S, BLC600216S, BLC600217S, BLC600218S, BLC600219S, BLC600221S, BLC600222S, BLC600223S, BLC600224S, BLC600225S, BLC600227S, BLC600228S, BLC600230S, BLC600231S, BLC600080S, BLC600207S, BLC600426S, BLC600455S, BLC600519S, BLC600058S, BLC600348S, BLC600022S, BLC600297S, BLC600316S, BLC600371S, BLC600121S, BLC600130S, BLC600131S, BLC600132S, BLC600159S, BLC600403S, BLC600508S, BLC600047S, BLC600342S, BLC600317S, BLC600525S, BLC600429S, BLC600145S, BLC600038S, BLC600039S, BLC600040S, BLC600256S, BLC600257S, BLC600258S, BLC600183S, BLC600296S, BLC600331S, BLC600381S, BLC600477S
Other Recalls from Medtronic Inc., Cardiac Rhythm and He...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1707-2023 | Class I | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Num... | May 10, 2023 |
| Z-1737-2023 | Class I | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Numbe... | May 10, 2023 |
| Z-1722-2023 | Class I | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model N... | May 10, 2023 |
| Z-1746-2023 | Class I | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number... | May 10, 2023 |
| Z-1739-2023 | Class I | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model ... | May 10, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.