Fusion Bioline Vascular Graft, Part number M00201503046B0
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00384409005942 Lot 25162546
- 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:
- Maquet Cardiovascular, LLC
- Reason for Recall:
- One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Fusion Bioline Vascular Graft, Part number M00201503046B0
Product Codes/Lot Numbers:
UDI-DI 00384409005942 Lot 25162546
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1245-2023
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Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
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Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.