FDA Medical Device Recalls (openFDA)
Abbott Medical: Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
- Recall number
- Z-0495-2025
- Recalling firm
- Abbott Medical
- Product
- Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
- Status
- Open, Classified
- Initiated
- 2024-10-17
- Posted
- 2024-11-20
- Terminated
- not on file
- 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. 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).
- Quantity
- 5 OUS
- Distribution
- New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
- Lot, serial or model codes
- UDI-DI (GTIN): 5415067031594, Serial Numbers: 20110016, 20155472, 20155476, 20166304, & 20168050.
- 510(k) numbers
- not on file
- PMA numbers
- ["P190023"]
- Product code
- NPT
- Firm FEI
- 3007113487
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28