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FDAOctober 17, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott medicalabbott

UPCs

5415067031600

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile — Recall Details · AllClear