Abbott Medical recalls specific 27mm 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 27mm Transcatheter Aortic Heart Valves that may have manufacturing defects affecting long-term durability. This could lead to valve failure over time, requiring medical attention.
A manufacturing error caused some valves to have leaflet deflection values outside normal specifications. This could reduce the valve's long-term durability and potentially cause failure over time.
Patients who received the recalled valves during surgery are most at risk. The recall applies to specific serial numbers and UDI-DI codes used in medical procedures.
Check the serial numbers listed: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, and 20213055. Also verify the UDI-DI (GTIN) code 5415067045799.
Compare your valve's serial number with the listed numbers: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, and 20213055.
A manufacturing error caused some valves to have leaflet deflection values outside normal specifications, which could affect long-term durability.
Check the serial numbers listed: 20158135, 20172203, 20183968, 20184552, 20184670, 20184675, 20190249, and 20213055. Also verify the UDI-DI (GTIN) code 5415067045799.
The recall does not specify a remedy, so 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-0494-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0494-2025 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.
