Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile

FDA device recall Z-0491-2025 · posted 2024-11-20 · Open, Classified

Recall details

Recalling firm

Abbott Medical

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.

Action taken

A Medical Device Recall letter was hand delivered Oct. 21, 2024 to the one US consignee for 1 Impacted Valve. Nine foreign consignees were also notified for 26 Impacted Valves distributed outside of the United States (OUS). Customers are advised to return any remaining unused Impacted Valves, if applicable, and complete and return the accompanying Acknowledgement Form to Abbott. Abbott is executing further testing to verify that long-term durability of the Impacted Valves has not been affected and will communicate any changes to the recommendations set forth in this letter if needed by Q4 2025. In the interim, Abbott recommends continuing the same local standard of care in patients implanted with the Impacted Valve as would be used with patients implanted with any other transcatheter aortic valve implant. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664 (Option 2).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NPT

Quantity affected

1 US, 9 OUS

Distribution

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

Date initiated

2024-10-17

Date posted

2024-11-20

Location

Saint Paul, MN