--- title: "CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardiove... — FDA record Z-1746-2023 | Is It on Recall" description: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)" url: https://isitonrecall.com/recall/fda-device-z-1746-2023-crt-d-dtbb2d4-viva-s-is1-df4-intl-model-number-dtbb2d4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators — FDA record Z-1746-2023 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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**: 435 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1746-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1746-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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 00643169720299, Lot Serial Numbers; BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S; GTIN 00643169980112, Lot Serial Numbers: BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, BLR602537S, BLR602540S, BLR602542S, BLR602544S, BLR602545S, BLR602546S, BLR602548S, BLR602550S, BLR602552S, BLR602554S, BLR602555S, BLR602587S, BLR602632S, BLR602633S, BLR602638S, BLR602639S, BLR602640S, BLR602644S, BLR602645S, BLR602647S, BLR602669S, BLR602670S, BLR602672S, BLR602682S, BLR602710S, BLR602711S, BLR602751S, BLR602752S, BLR602753S, BLR602754S, BLR602760S, BLR602763S, BLR602770S, BLR602773S, BLR602787S, BLR602788S, BLR602789S, BLR602790S, BLR602791S, BLR602792S, BLR602793S, BLR602794S, BLR602795S, BLR602796S, BLR602797S, BLR602818S, BLR602820S, BLR602476S, BLR602480S, BLR602514S, BLR602539S, BLR602556S, BLR602558S, BLR602567S, BLR602601S, BLR602648S, BLR602665S, BLR602678S, BLR602684S, BLR602687S, BLR602688S, BLR602706S, BLR602713S, BLR602756S, BLR602757S, BLR602784S, BLR602557S, BLR602344S, BLR602321S, BLR602343S, BLR602423S, BLR602319S, BLR602320S, BLR602345S, BLR602346S, BLR602426S, BLR602427S, BLR602436S, BLR602437S, BLR602445S, BLR602446S, BLR602447S, BLR602448S, BLR602449S, BLR602461S, BLR602465S, BLR602466S, BLR602468S, BLR602479S, BLR602481S, BLR602519S, BLR602521S, BLR602523S, BLR602526S, BLR602527S, BLR602529S, BLR602532S, BLR602533S, BLR602566S, BLR602616S, BLR602728S, BLR602438S, BLR602460S, BLR602495S, BLR602570S, BLR602464S, BLR602497S, BLR602525S, BLR602439S, BLR602467S, BLR602494S, BLR602517S, BLR602444S, BLR602469S, BLR602489S, BLR602524S, BLR602498S, BLR602522S, BLR602528S, BLR602538S, BLR602750S, BLR602772S, BLR602443S, BLR602482S, BLR602571S, BLR602586S, BLR602652S, BLR602664S, BLR602717S, BLR602718S, BLR602732S, BLR602740S, BLR602764S, BLR602699S, BLR602700S, BLR602701S, BLR602722S, BLR602744S, BLR602745S, BLR602582S, BLR602583S, BLR602809S, BLR602683S, BLR602737S, BLR602738S, BLR602801S, BLR602564S, BLR602681S, BLR602724S, BLR602726S, BLR602731S, BLR602765S, BLR602815S, BLR602565S, BLR602624S, BLR602813S, BLR602811S, BLR602580S, BLR602808S, BLR602762S, BLR602735S, BLR602677S, BLR602457S, BLR602661S, BLR602643S, BLR602653S, BLR602662S, BLR602630S, BLR602679S, BLR602680S, BLR602723S, BLR602729S, BLR602503S, BLR602510S, BLR602512S, BLR602421S, BLR602577S, BLR602440S, BLR602441S, BLR602442S, BLR602452S, BLR602453S, BLR602454S, BLR602572S, BLR602573S, BLR602592S, BLR602593S, BLR602594S, BLR602599S, BLR602622S, BLR602626S, BLR602627S, BLR602631S, BLR602634S, BLR602635S, BLR602636S, BLR602637S, BLR602641S, BLR602642S, BLR602651S, BLR602654S, BLR602655S, BLR602656S, BLR602657S, BLR602658S, BLR602666S, BLR602671S, BLR602673S, BLR602685S, BLR602686S, BLR602689S, BLR602690S, BLR602692S, BLR602694S, BLR602698S, BLR602704S, BLR602714S, BLR602715S, BLR602719S, BLR602727S, BLR602741S, BLR602742S, BLR602743S, BLR602746S, BLR602747S, BLR602748S, BLR602749S, BLR602755S, BLR602758S, BLR602767S, BLR602806S, BLR602807S, BLR602705S, BLR602581S, BLR602730S, BLR602628S, BLR602629S, BLR602674S, BLR602675S, BLR602695S, BLR602707S, BLR602804S, BLR602814S, BLR602816S, BLR602578S, BLR602455S, BLR602614S, BLR602663S, BLR602761S, BLR602771S, BLR602798S, BLR602799S, BLR602800S, BLR602619S, BLR602620S, BLR602621S, BLR602650S, BLR602660S, BLR602734S, BLR602766S, BLR602768S, BLR602812S, BLR602667S, BLR602708S, BLR602473S, BLR602477S, BLR602649S, BLR602591S, BLR602668S, BLR602576S, BLR602720S, BLR602823S, BLR602611S, BLR602420S, BLR602563S, BLR602721S, BLR602623S, BLR602625S, BLR602702S, BLR602703S, BLR602709S, BLR602458S, BLR602691S, BLR602612S, BLR602676S, BLR602725S, BLR602588S, BLR602805S, BLR602513S, BLR602474S, BLR602475S, BLR602478S, BLR602483S, BLR602484S, BLR602485S, BLR602486S, BLR602487S, BLR602491S, BLR602499S, BLR602500S, BLR602501S, BLR602502S, BLR602504S, BLR602505S, BLR602506S, BLR602508S, BLR602509S, BLR602511S, BLR602541S, BLR602543S, BLR602547S, BLR602549S, BLR602551S, BLR602553S, BLR602559S, BLR602561S, BLR602562S, BLR602568S, BLR602569S, BLR602574S, BLR602575S, BLR602579S, BLR602584S, BLR602585S, BLR602589S, BLR602590S, BLR602595S, BLR602596S, BLR602597S, BLR602598S, BLR602600S, BLR602602S, BLR602603S, BLR602605S, BLR602607S, BLR602608S, BLR602609S, BLR602610S, BLR602613S, BLR602615S, BLR602617S, BLR602659S, BLR602646S, BLR602693S, BLR602733S, BLR602774S, BLR602775S, BLR602776S, BLR602786S, BLR602802S, BLR602716S; GTIN 00763000612283, Lot Serial Numbers: BLR602824S, BLR602825S, BLR602826S, BLR602830S, BLR602831S, BLR602832S, BLR602833S, BLR602834S, BLR602835S, BLR602836S | 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](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1746-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) records](https://isitonrecall.com/brand/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/)