CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM203031H, BLM203063H, BLM202844H, BLM202900H, BLM203042H, BLM203014H, BLM203015H, BLM203062H, BLM202811H, BLM202838H, BLM202857H, BLM202858H, BLM202881H, BLM202923H, BLM203001H, BLM203021H, BLM202848H, BLM202878H, BLM202827H, BLM202952H, BLM203061H, BLM202909H, BLM202921H, BLM202942H, BLM202830H, BLM202850H, BLM202886H, BLM202888H, BLM202829H, BLM202911H, BLM202958H, BLM202982H, BLM203037H, BLM202945H, BLM202929H, BLM202949H, BLM202973H, BLM202828H, BLM202990H, BLM202947H, BLM202960H, BLM202854H, BLM202944H, BLM202810H, BLM202847H, BLM202862H, BLM202880H, BLM202904H, BLM202946H, BLM202974H, BLM202979H, BLM203006H, BLM203012H, BLM203040H, BLM202932H, BLM202913H, BLM202940H, BLM202842H, BLM202980H, BLM203029H, BLM203058H, BLM203065H, BLM202972H, BLM203051H, BLM202867H, BLM202948H, BLM203004H, BLM202832H, BLM202999H, BLM202885H, BLM202976H, BLM203035H, BLM203009H, BLM203024H, BLM202914H, BLM203002H, BLM202833H, BLM202983H, BLM202985H, BLM202986H, BLM202987H, BLM202988H, BLM202992H, BLM202996H, BLM203003H, BLM203005H, BLM203008H, BLM203016H, BLM203022H, BLM203043H, BLM203046H, BLM203047H, BLM203048H, BLM203049H, BLM203066H, BLM202851H, BLM202852H, BLM202866H, BLM202875H, BLM202984H, BLM203026H, BLM203054H, BLM202860H, BLM202927H, BLM202846H, BLM202943H, BLM202951H, BLM202989H, BLM202876H, BLM202825H, BLM202915H, BLM202954H, BLM202849H, BLM202836H, BLM203053H, BLM203064H, BLM203067H
- 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:
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Product Codes/Lot Numbers:
GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM203031H, BLM203063H, BLM202844H, BLM202900H, BLM203042H, BLM203014H, BLM203015H, BLM203062H, BLM202811H, BLM202838H, BLM202857H, BLM202858H, BLM202881H, BLM202923H, BLM203001H, BLM203021H, BLM202848H, BLM202878H, BLM202827H, BLM202952H, BLM203061H, BLM202909H, BLM202921H, BLM202942H, BLM202830H, BLM202850H, BLM202886H, BLM202888H, BLM202829H, BLM202911H, BLM202958H, BLM202982H, BLM203037H, BLM202945H, BLM202929H, BLM202949H, BLM202973H, BLM202828H, BLM202990H, BLM202947H, BLM202960H, BLM202854H, BLM202944H, BLM202810H, BLM202847H, BLM202862H, BLM202880H, BLM202904H, BLM202946H, BLM202974H, BLM202979H, BLM203006H, BLM203012H, BLM203040H, BLM202932H, BLM202913H, BLM202940H, BLM202842H, BLM202980H, BLM203029H, BLM203058H, BLM203065H, BLM202972H, BLM203051H, BLM202867H, BLM202948H, BLM203004H, BLM202832H, BLM202999H, BLM202885H, BLM202976H, BLM203035H, BLM203009H, BLM203024H, BLM202914H, BLM203002H, BLM202833H, BLM202983H, BLM202985H, BLM202986H, BLM202987H, BLM202988H, BLM202992H, BLM202996H, BLM203003H, BLM203005H, BLM203008H, BLM203016H, BLM203022H, BLM203043H, BLM203046H, BLM203047H, BLM203048H, BLM203049H, BLM203066H, BLM202851H, BLM202852H, BLM202866H, BLM202875H, BLM202984H, BLM203026H, BLM203054H, BLM202860H, BLM202927H, BLM202846H, BLM202943H, BLM202951H, BLM202989H, BLM202876H, BLM202825H, BLM202915H, BLM202954H, BLM202849H, BLM202836H, BLM203053H, BLM203064H, BLM203067H
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1743-2023
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