Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI 00643169297913, Serial Numbers: 935603, 935732
- 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 ATS MEDICAL, INC.
- Reason for Recall:
- Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Product Codes/Lot Numbers:
UDI 00643169297913, Serial Numbers: 935603, 935732
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1533-2020
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