medical Class II Updated 2024-11-27

Abbott Medical recalls Abbott Navitor Titan, Vision Technology, Transcatheter Aorti

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

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

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

View official government recall

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