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SynCardia Systems LLC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SynCardia Systems LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-11-01FDA-DeviceClass IISynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
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