Artivion, Inc. has recalled one unit of the CryoValve SG Cryopreserved Pulmonary Human Heart Valve because blood cultures taken during the organ donation process tested positive for Staphylococcus aureus, a type of bacteria. This specific valve, identified by Serial ID Number 12578856, was distributed in Ohio and has an expiration date of April 5, 2028. Because this is an implanted medical device, consumers who may have received this valve should consult their healthcare provider immediately to discuss potential health impacts and monitoring.
The presence of Staphylococcus aureus in an implanted heart valve can lead to serious infections, including endocarditis or sepsis, which may require medical or surgical intervention.
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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