Recall Z-0493-2025 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Abbott Medical
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
| Date | Nov 20, 2024 (initiated Oct 17, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 3 OUS |
| Distribution | New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.