Class II

Medical Device Recall: Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

Abbott Medical · October 17, 2024

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 Affected

1 OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0492-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.