--- title: "ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter ... — FDA record Z-1794-2023 | 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-1794-2023-icd-vr-visia-af-s-us-ous-df4-model-number-dvac3d4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators — FDA record Z-1794-2023 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**: ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; 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**: 194 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1794-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1794-2023%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 00643169720787, Lot Serial Numbers: BWV600051S, BWV600052S, BWV600078S, BWV600079S, BWV600010S, BWV600094S, BWV600024S, BWV600027S, BWV600031S, BWV600032S, BWV600041S, BWV600042S, BWV600043S, BWV600044S, BWV600045S, BWV600046S, BWV600047S, BWV600068S, BWV600069S, BWV600070S, BWV600071S, BWV600072S, BWV600073S, BWV600074S, BWV600087S, BWV600088S, BWV600089S, BWV600090S, BWV600099S, BWV600101S, BWV600105S, BWV600107S, BWV600108S, BWV600109S, BWV600110S, BWV600111S, BWV600112S, BWV600113S, BWV600114S, BWV600115S, BWV600155S, BWV600157S, BWV600160S, BWV600161S, BWV600162S, BWV600163S, BWV600164S, BWV600165S, BWV600166S, BWV600167S, BWV600168S, BWV600170S, BWV600171S, BWV600172S, BWV600173S, BWV600174S, BWV600175S, BWV600176S, BWV600177S, BWV600178S, BWV600179S, BWV600180S, BWV600181S, BWV600183S, BWV600184S, BWV600185S, BWV600186S, BWV600187S, BWV600022S, BWV600025S, BWV600026S, BWV600028S, BWV600029S, BWV600030S, BWV600033S, BWV600034S, BWV600035S, BWV600036S, BWV600037S, BWV600038S, BWV600039S, BWV600040S, BWV600048S, BWV600049S, BWV600050S, BWV600055S, BWV600056S, BWV600057S, BWV600058S, BWV600059S, BWV600060S, BWV600061S, BWV600062S, BWV600063S, BWV600064S, BWV600065S, BWV600066S, BWV600067S, BWV600080S, BWV600081S, BWV600082S, BWV600083S, BWV600084S, BWV600085S, BWV600086S, BWV600091S, BWV600092S, BWV600093S, BWV600095S, BWV600096S, BWV600100S, BWV600103S, BWV600116S, BWV600117S, BWV600118S, BWV600119S, BWV600120S, BWV600121S, BWV600122S, BWV600123S, BWV600124S, BWV600125S, BWV600126S, BWV600127S, BWV600128S, BWV600129S, BWV600130S, BWV600131S, BWV600132S, BWV600133S, BWV600134S, BWV600135S, BWV600136S, BWV600137S, BWV600138S, BWV600139S, BWV600140S, BWV600141S, BWV600142S, BWV600143S, BWV600144S, BWV600145S, BWV600146S, BWV600147S, BWV600148S, BWV600149S, BWV600151S, BWV600102S, BWV600097S; GTIN 00763000052720, Lot Serial Numbers: BWV600261S, BWV600263S, BWV600265S, BWV600267S, BWV600258S, BWV600259S, BWV600284S, BWV600285S, BWV600286S, BWV600287S, BWV600288S, BWV600289S, BWV600290S, BWV600291S, BWV600292S, BWV600293S, BWV600294S, BWV600295S, BWV600296S, BWV600297S, BWV600298S, BWV600300S, BWV600301S, BWV600302S, BWV600303S, BWV600304S, BWV600305S, BWV600306S, BWV600307S, BWV600308S, BWV600309S, BWV600310S, BWV600311S, BWV600312S, BWV600313S, BWV600314S, BWV600315S, BWV600316S, BWV600317S, BWV600318S, BWV600320S, BWV600266S, BWV600260S, BWV600262S, BWV600264S | 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-1794-2023%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/)