Abbott Navitor Transcatheter Aortic Heart Valve — Class II medical device recall Z-0495-2025
Ongoing recall by Abbott Medical, reported 2024-11-27, distributed in NY. A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of es
| Recall number | Z-0495-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Saint Paul, MN, United States |
| Recall initiated | 2024-10-17 |
| Classified | 2024-11-20 |
| Reported by FDA | 2024-11-27 |
| Distributed | NY |
| Countries outside the US | AU, BE, DE, ES, GB, IL, IR, JP, OM, PL, RO, SK, TR |
| Quantity | 5 ous |
| UPC / GTIN / UDI-DI | 05415067031594 |
| Serial numbers | 20110016, 20155472, 20155476, 20166304, 20168050 |
Product
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0495-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.