medical Class II Updated 2024-11-27

Abbott Medical recalls Abbot Navitor, Vision Technology, Transcatheter Aortic Heart

Recalled Product

Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, 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): 5415067045775, Serial Numbers: 20150441, 20156804, & 20170535
View official government recall

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