Abbott Medical: Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile

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.

Details from the source

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. Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. Quantity: 8 OUS Lot/code info: UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.

UPC codes

5415067045799

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.