Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.
- 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:
- Abbott Medical
- Reason for Recall:
- A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Product Codes/Lot Numbers:
UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0495-2025
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