ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR600959S, BWR601046S, BWR600938S, BWR601096S, BWR601093S, BWR600979S, BWR601092S, BWR600997S, BWR600934S, BWR600965S, BWR601050S, BWR601049S, BWR600823S, BWR601053S, BWR600983S, BWR600989S, BWR600984S, BWR601055S, BWR601057S, BWR601098S, BWR600822S, BWR600980S, BWR600981S, BWR600982S, BWR601097S, BWR601100S, BWR601095S, BWR601101S, BWR600991S, BWR601051S, BWR601058S, BWR601099S, BWR601094S; GTIN BWR601149S, BWR601155S, BWR601137S, BWR601138S, BWR601108S, BWR601113S, BWR601111S, BWR601119S, BWR601144S, BWR601146S, BWR601147S, BWR601148S, BWR601067S, BWR601150S, BWR601152S, BWR601115S, BWR601105S, BWR601112S, BWR601059S, BWR601061S, BWR601062S, BWR601063S, BWR601072S, BWR601073S, BWR601078S, BWR601081S, BWR601090S, BWR601116S, BWR601103S, BWR601075S, BWR601102S, BWR601104S
- 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 XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
Product Codes/Lot Numbers:
GTIN 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR600959S, BWR601046S, BWR600938S, BWR601096S, BWR601093S, BWR600979S, BWR601092S, BWR600997S, BWR600934S, BWR600965S, BWR601050S, BWR601049S, BWR600823S, BWR601053S, BWR600983S, BWR600989S, BWR600984S, BWR601055S, BWR601057S, BWR601098S, BWR600822S, BWR600980S, BWR600981S, BWR600982S, BWR601097S, BWR601100S, BWR601095S, BWR601101S, BWR600991S, BWR601051S, BWR601058S, BWR601099S, BWR601094S; GTIN BWR601149S, BWR601155S, BWR601137S, BWR601138S, BWR601108S, BWR601113S, BWR601111S, BWR601119S, BWR601144S, BWR601146S, BWR601147S, BWR601148S, BWR601067S, BWR601150S, BWR601152S, BWR601115S, BWR601105S, BWR601112S, BWR601059S, BWR601061S, BWR601062S, BWR601063S, BWR601072S, BWR601073S, BWR601078S, BWR601081S, BWR601090S, BWR601116S, BWR601103S, BWR601075S, BWR601102S, BWR601104S
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1791-2023
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