Recall Z-0495-2025— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2024-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile. Reason: 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..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-17
- Firm location
- Saint Paul, MN, United States
Product description
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.