Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, 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.

Code information: UDI-DI (GTIN): 05415067045768, Serial Numbers: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, & 20358370.

Distribution pattern: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.