Abbott Medical recalls specific 35mm Transcatheter Aortic Heart Valves due to possible long-term durability issues. Affected units have unique serial numbers and GTIN codes. Consumers should 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 35mm Transcatheter Aortic Heart Valves that may have manufacturing defects affecting long-term durability. This could lead to valve failure, requiring medical intervention.
A manufacturing error caused some valves to have leaflet deflection values outside acceptable limits. 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 affects specific units with unique serial numbers and GTIN codes.
Check for the serial numbers listed in the recall notice: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, and 20358370. Also look for the GTIN code 05415067045768 on the valve packaging.
Reach out to Abbott Medical directly for specific guidance on affected units and next steps.
A manufacturing error caused some valves to have leaflet deflection values outside acceptable limits, which could affect long-term durability.
Contact Abbott Medical directly for specific guidance on affected units and next steps.
Check for the serial numbers listed: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, and 20358370. Also look for the GTIN code 05415067045768 on the valve packaging.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2025 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-0491-2025 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.
