Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Recall Insight

This FDA Devices action (record #Z-0495-2025) was formally reported on November 27, 2024, with the manufacturer initiating the action on October 17, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Medical is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 5 OUS units are affected.

The documented reason for this recall is: 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 cau… Distribution data in the federal record shows the product reached: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.