CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN 00643169720329, Lot Serial Numbers: BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO214404H, BLO214407H, BLO214280H, BLO214416H, BLO214517H, BLO214533H, BLO214558H, BLO214452H, BLO214527H, BLO214377H, BLO214491H, BLO214460H, BLO214502H, BLO214469H, BLO214471H, BLO214506H, BLO214427H, BLO214320H, BLO214434H, BLO214453H, BLO214467H, BLO214512H, BLO214313H, BLO214447H, BLO214449H, BLO214485H, BLO214318H, BLO214415H, BLO214324H, BLO214477H, BLO214454H, BLO214281H, BLO214569H, BLO214385H, BLO214509H, BLO214419H, BLO214420H, BLO214443H, BLO214363H, BLO214520H, BLO214306H, BLO214298H, BLO214340H, BLO214503H, BLO214504H, BLO214505H, BLO214378H, BLO214451H, BLO214332H, BLO214486H, BLO214382H, BLO214286H, BLO214364H, BLO214381H, BLO214386H, BLO214406H, BLO214459H, BLO214326H, BLO213864H, BLO214408H, BLO214426H, BLO214488H, BLO214293H, BLO214264H, BLO214305H, BLO214337H, BLO214388H, BLO214432H, BLO214489H, BLO214357H, BLO214389H, BLO214392H, BLO214411H, BLO214455H, BLO214461H, BLO214494H, BLO214284H, BLO214474H, BLO214507H, BLO214555H, BLO214560H, BLO214572H, BLO214573H, BLO214576H, BLO214373H, BLO214508H
- 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 DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Product Codes/Lot Numbers:
GTIN 00643169720329, Lot Serial Numbers: BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO214404H, BLO214407H, BLO214280H, BLO214416H, BLO214517H, BLO214533H, BLO214558H, BLO214452H, BLO214527H, BLO214377H, BLO214491H, BLO214460H, BLO214502H, BLO214469H, BLO214471H, BLO214506H, BLO214427H, BLO214320H, BLO214434H, BLO214453H, BLO214467H, BLO214512H, BLO214313H, BLO214447H, BLO214449H, BLO214485H, BLO214318H, BLO214415H, BLO214324H, BLO214477H, BLO214454H, BLO214281H, BLO214569H, BLO214385H, BLO214509H, BLO214419H, BLO214420H, BLO214443H, BLO214363H, BLO214520H, BLO214306H, BLO214298H, BLO214340H, BLO214503H, BLO214504H, BLO214505H, BLO214378H, BLO214451H, BLO214332H, BLO214486H, BLO214382H, BLO214286H, BLO214364H, BLO214381H, BLO214386H, BLO214406H, BLO214459H, BLO214326H, BLO213864H, BLO214408H, BLO214426H, BLO214488H, BLO214293H, BLO214264H, BLO214305H, BLO214337H, BLO214388H, BLO214432H, BLO214489H, BLO214357H, BLO214389H, BLO214392H, BLO214411H, BLO214455H, BLO214461H, BLO214494H, BLO214284H, BLO214474H, BLO214507H, BLO214555H, BLO214560H, BLO214572H, BLO214573H, BLO214576H, BLO214373H, BLO214508H
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1741-2023
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