Abbott Medical recalls 29mm Navitor Transcatheter Aortic Heart Valves with possible durability concerns. Affected units have specific UDI-DI and serial numbers. 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 29mm Navitor Transcatheter Aortic Heart Valves due to potential long-term durability issues. This could lead to valve failure or reduced longevity in some patients.
A manufacturing error caused some valves to have leaflet deflection values outside acceptable limits. This might reduce the valve's long-term durability or cause failure over time.
Patients who received the recalled valve during surgery. Those with the specific UDI-DI (GTIN) and serial number are most at risk.
Check for the UDI-DI (GTIN) 54150:67031600 and serial number 20131478 on the valve packaging or device. The valve model is 29mm Navitor Transcatheter Aortic Heart Valve.
Reach out to Abbott Medical directly for specific guidance on the recalled valve model and serial numbers.
The recall indicates potential long-term durability issues, but not an immediate hazard. The valve may fail over time in some cases.
Check for the UDI-DI (GTIN) 5415067031600 and serial number 20131478 on the valve packaging or device.
Contact Abbott Medical directly for specific guidance on the recalled valve model and serial numbers.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0492-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0492-2025 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.
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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.
