Abbott Medical has issued a voluntary recall for 18 Navitor Transcatheter Aortic Heart Valves due to a manufacturing error. This error allowed valves to be produced with leaflets that do not meet thickness or movement specifications. No incidents or injuries have been reported to date, but the defect could cause the heart valve to fail or wear out much sooner than expected. The recall affects specific serial numbers of the 27 mm, 29 mm, and 35 mm valve sizes.
The valve leaflets may not deflect correctly during use, which can lead to reduced durability or total failure of the heart valve implant. This could potentially cause serious health complications for patients who have had these specific valves implanted.
1 US unit and 9 OUS units affected.
1 OUS unit affected.
3 OUS units affected.
8 OUS units affected.
5 OUS units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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