Abbott Medical recalls specific 29mm Transcatheter Aortic Heart Valves due to possible long-term durability problems from manufacturing errors. Affected units have unique serial numbers and UDI-DI codes.
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 Transcatheter Aortic Heart Valves (NVRO-29) because a manufacturing error might cause long-term durability issues or valve failure. This recall affects patients who received these specific valves during surgery.
A manufacturing error caused some valves to have leaflet deflection values outside normal specifications. This could lead to reduced long-term durability or valve failure over time, but does not cause immediate harm during normal use.
Patients who received the recalled valves during surgery are most at risk. The recall applies to specific serial numbers and UDI-DI codes of the valves.
Check if your valve has serial numbers 20150441, 2:0156804, or 20170535. Also look for UDI-DI code 5415067045775 on the valve packaging or documentation.
Review your valve's serial numbers and UDI-DI code to confirm if it matches the recalled units (serials: 20150441, 20156804, 20170535; UDI-DI: 5415067045775).
A manufacturing error resulted in some valves having leaflet deflection values outside normal specifications, which could affect long-term durability or cause valve failure.
Check your valve's serial numbers and UDI-DI code to see if it matches the recalled units. If it does, contact Abbott Medical for further instructions.
The recall states potential long-term durability issues or valve failure, but does not indicate immediate injury risks during normal use.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0493-2025 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.
