FDA Medical devices recall ·
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve… recall
- Recall number
- Z-0491-2025
- Date
- (initiated October 17, 2024)
- Company / brand
- Abbott Medical
177 E County Road B, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 US, 9 OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (GTIN): 05415067045768, Serial Numbers: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, & 20358370.
Distribution
New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
States: New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0491-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.