ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1794-2023
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