SynCardia Systems LLC is recalling 114 units of the SynCardia 50cc TAH-t (Total Artificial Heart) because the devices contain an epoxy resin that has not been reviewed by the FDA for safety and efficacy. This specific recall affects the clinical model (REF 570500) which was distributed to several medical facilities across the United States and multiple international locations. Consumers and healthcare providers should be aware that the safety profile of this unreviewed material is unknown. You should contact your healthcare provider or the manufacturer immediately for further instructions regarding this device.
The use of an epoxy resin that has not been evaluated by the FDA means the long-term safety and performance of the device's materials cannot be guaranteed, potentially posing unknown health risks to patients with these implants.
Manufacturer Notification and Medical Guidance
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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