Abbott Medical recalls 27mm Navitor Transcatheter Aortic Heart Valves with possible durability concerns. Affected units have specific serial numbers and UDI-DI codes. Contact Abbott for details.
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.
Abbott Medical is recalling certain 27mm Navitor Transcatheter Aortic Heart Valves due to potential long-term durability issues. This could lead to valve failure or reduced effectiveness over time.
A manufacturing error caused some valves to have leaflet deflection values outside normal specifications. This could affect how well the valve functions long-term and might lead to failure.
Patients who received the recalled valve during surgery are most at risk. The recall affects specific units with known serial numbers and UDI-DI codes.
Check the serial numbers: 20110016, 20155472, 20155476, 20166304, or 20168050. Also verify the UDI-DI code (GTIN): 5415067031594.
Look for the serial numbers listed: 20110016, 20155472, 20155476, 20166304, or 20168050.
A manufacturing error caused some valves to have leaflet deflection values outside normal specifications, which could affect long-term durability.
Check the serial numbers: 20110016, 20155472, 20155476, 20166304, or 20168050. Also verify the UDI-DI code (GTIN): 5415067031594.
Contact Abbott Medical directly for guidance on next steps.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0495-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0495-2025 from Abbott Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
