Abbott Medical: Medical Device Recall in 2024 - (Recall #: Z-0494-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 17, 2024

Date Posted: November 27, 2024

Recall Number: Z-0494-2025

Event ID: 95627

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.

Status: Ongoing

Product Quantity: 8 OUS

Code Information:

UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated