ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H, BWP202381H, BWP202303H, BWP202223H, BWP202409H, BWP202249H, BWP202173H, BWP202158H, BWP202635H, BWP202415H, BWP202438H, BWP202177H, BWP202315H, BWP202360H, BWP202372H, BWP202388H, BWP202451H, BWP202498H, BWP202500H, BWP202504H, BWP202507H, BWP202515H, BWP202525H, BWP202531H, BWP202584H, BWP202589H, BWP202290H, BWP202237H, BWP202330H, BWP201862H, BWP202199H, BWP202256H, BWP202396H, BWP202378H, BWP202368H, BWP202356H, BWP202459H, BWP202167H, BWP202380H, BWP202230H, BWP202400H, BWP202236H, BWP202335H, BWP202351H, BWP202539H, BWP202574H, BWP202575H, BWP202596H, BWP202633H, BWP202476H, BWP202478H, BWP202479H, BWP202480H, BWP202481H, BWP202482H, BWP202343H, BWP202206H, BWP202251H, BWP202345H, BWP202352H, BWP202386H, BWP202205H, BWP202433H, BWP202340H, BWP202556H, BWP202286H, BWP202234H, BWP202169H, BWP202259H, BWP202263H, BWP202214H, BWP202216H, BWP202220H, BWP202248H, BWP202310H, BWP202552H, BWP202597H, BWP202410H, BWP202240H, BWP202243H, BWP202328H, BWP202464H, BWP202568H, BWP202170H, BWP202411H, BWP202276H, BWP202221H, BWP202178H, BWP202538H, BWP202551H, BWP202174H, BWP202289H, BWP202483H, BWP202485H, BWP202486H, BWP202608H, BWP202232H, BWP202241H, BWP202245H, BWP202253H, BWP202264H, BWP202313H, BWP202323H, BWP202336H, BWP202339H, BWP202341H, BWP202346H, BWP202370H, BWP202383H, BWP202389H, BWP202393H, BWP202395H, BWP202423H, BWP202436H, BWP202441H, BWP202442H, BWP202445H, BWP202448H, BWP202463H, BWP202487H, BWP202492H, BWP202501H, BWP202509H, BWP202511H, BWP202512H, BWP202513H, BWP202517H, BWP202518H, BWP202533H, BWP202555H, BWP202572H, BWP202581H, BWP202590H, BWP202244H, BWP202427H, BWP202428H, BWP202591H, BWP202599H, BWP202624H, BWP202305H, BWP202565H, BWP202625H
- 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 DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
Product Codes/Lot Numbers:
GTIN 00643169720626, Lot Serial Numbers: BWP202537H, BWP202379H, BWP202439H, BWP202454H, BWP202474H, BWP202510H, BWP202522H, BWP202523H, BWP202252H, BWP202639H, BWP202514H, BWP202179H, BWP202398H, BWP202399H, BWP202554H, BWP202420H, BWP202447H, BWP202494H, BWP201863H, BWP202260H, BWP202324H, BWP202359H, BWP202432H, BWP202542H, BWP202643H, BWP202292H, BWP202297H, BWP202365H, BWP202366H, BWP202369H, BWP202549H, BWP202578H, BWP202213H, BWP202287H, BWP202471H, BWP202583H, BWP201864H, BWP202626H, BWP202358H, BWP202331H, BWP202306H, BWP202385H, BWP202272H, BWP202404H, BWP202434H, BWP202453H, BWP202553H, BWP202576H, BWP202586H, BWP202588H, BWP202598H, BWP202544H, BWP202159H, BWP202161H, BWP202162H, BWP202163H, BWP202164H, BWP202165H, BWP202561H, BWP202563H, BWP202467H, BWP202194H, BWP202238H, BWP202460H, BWP202497H, BWP202198H, BWP202532H, BWP202566H, BWP202536H, BWP202180H, BWP202402H, BWP202424H, BWP202429H, BWP202183H, BWP202279H, BWP202362H, BWP202363H, BWP202364H, BWP202496H, BWP202291H, BWP202189H, BWP202338H, BWP202273H, BWP202488H, BWP202573H, BWP202508H, BWP202587H, BWP202349H, BWP202466H, BWP202354H, BWP202376H, BWP202455H, BWP202612H, BWP201861H, BWP202188H, BWP202284H, BWP202309H, BWP202168H, BWP202334H, BWP202381H, BWP202303H, BWP202223H, BWP202409H, BWP202249H, BWP202173H, BWP202158H, BWP202635H, BWP202415H, BWP202438H, BWP202177H, BWP202315H, BWP202360H, BWP202372H, BWP202388H, BWP202451H, BWP202498H, BWP202500H, BWP202504H, BWP202507H, BWP202515H, BWP202525H, BWP202531H, BWP202584H, BWP202589H, BWP202290H, BWP202237H, BWP202330H, BWP201862H, BWP202199H, BWP202256H, BWP202396H, BWP202378H, BWP202368H, BWP202356H, BWP202459H, BWP202167H, BWP202380H, BWP202230H, BWP202400H, BWP202236H, BWP202335H, BWP202351H, BWP202539H, BWP202574H, BWP202575H, BWP202596H, BWP202633H, BWP202476H, BWP202478H, BWP202479H, BWP202480H, BWP202481H, BWP202482H, BWP202343H, BWP202206H, BWP202251H, BWP202345H, BWP202352H, BWP202386H, BWP202205H, BWP202433H, BWP202340H, BWP202556H, BWP202286H, BWP202234H, BWP202169H, BWP202259H, BWP202263H, BWP202214H, BWP202216H, BWP202220H, BWP202248H, BWP202310H, BWP202552H, BWP202597H, BWP202410H, BWP202240H, BWP202243H, BWP202328H, BWP202464H, BWP202568H, BWP202170H, BWP202411H, BWP202276H, BWP202221H, BWP202178H, BWP202538H, BWP202551H, BWP202174H, BWP202289H, BWP202483H, BWP202485H, BWP202486H, BWP202608H, BWP202232H, BWP202241H, BWP202245H, BWP202253H, BWP202264H, BWP202313H, BWP202323H, BWP202336H, BWP202339H, BWP202341H, BWP202346H, BWP202370H, BWP202383H, BWP202389H, BWP202393H, BWP202395H, BWP202423H, BWP202436H, BWP202441H, BWP202442H, BWP202445H, BWP202448H, BWP202463H, BWP202487H, BWP202492H, BWP202501H, BWP202509H, BWP202511H, BWP202512H, BWP202513H, BWP202517H, BWP202518H, BWP202533H, BWP202555H, BWP202572H, BWP202581H, BWP202590H, BWP202244H, BWP202427H, BWP202428H, BWP202591H, BWP202599H, BWP202624H, BWP202305H, BWP202565H, BWP202625H
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1790-2023
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