FDAFDA · Food and drugs·Recall number Z-0492-2025
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Published November 27, 2024 · Recall initiated: October 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical
- Distributor
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Lot
- UDI-DI (GTIN): 5415067031600, Serial Number: 20131478
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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