Recall archive / 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. Source coverage and dates.
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
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 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
- 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.