Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

Recall date

October 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0492-2025

FDA classification

Class II

Brand / firm

Abbott Medical

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile