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Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Recalled November 27, 2024 · FDA recall Z-0492-2025 · Abbott Medical
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. · FDA Class II
Units
1 OUS
Sold at
New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Description
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.
Product
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Manufacturer(s)
Abbott Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →