Artivion, Inc. is recalling five human tissue cardiac grafts, including CryoValve SG Pulmonary Heart Valves and CryoPatch SG Pulmonary patches, because they were released and implanted using invalid test results. This recall affects 2 heart valves, 2 hemi-artery patches, and 1 branch patch that were distributed to medical facilities in California, Florida, New York, and Washington D.C. Because these products are surgical implants, consumers should contact their healthcare provider to discuss the status of their graft and any necessary follow-up care.
The use of grafts with invalid test results means the safety or sterility of the tissue cannot be fully guaranteed, which could potentially lead to complications or the need for additional medical monitoring following the implant procedure.
Healthcare provider consultation
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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