Z-0491-2025Class II

Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile

Name: Z-0491-2025 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Creator: Abbott Medical
Published: 2024-10-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-10-17 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Medical began a recall of Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile on 2024-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0491-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-17
Posted: 2024-11-20
Recalling firm: Abbott Medical
Product: Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 US, 9 OUS
Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
Product codes and lots: UDI-DI (GTIN): 05415067045768, Serial Numbers: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, & 20358370.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0491-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0491-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0492-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0493-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0494-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20
Z-0495-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)