Medical Device Recall: Z-0494-2025

FDA Recalls dataset · Firm: Abbott Medical · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2024-10-17 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0494-2025.

Recall Res Number
Z-0494-2025
Recalling Firm / Manufacturer
Abbott Medical
FEI Number
3007113487
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2024-10-17
Date Posted
2024-11-20
Date Terminated
N/A
Product Code
NPT
Event Number
95627
Product Quantity
8 OUS
Product Description Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-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.
Action Details 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).
Distribution Pattern New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Code Information / Serial Numbers UDI-DI (GTIN): 5415067045799, Serial Numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, & 20213055.

Related Establishments / Registrations

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