Recall Z-0492-2025
Abbott Medical · initiated October 17, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Codes / lots: UDI-DI (GTIN): 5415067031600, Serial Number: 20131478
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.
FDA-determined cause: Under Investigation by firm
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).
Details
- Recall number
- Z-0492-2025
- Initiated
- October 17, 2024
- Posted by FDA
- November 20, 2024
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- Quantity
- 1 OUS
- Distribution
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Recalling firm
- Abbott Medical, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0491-2025 Class II | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0493-2025 Class II | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0494-2025 Class II | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27…A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |
| Z-0495-2025 Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileA manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of… | 10/17/2024Open, Classified |