SynCardia Artificial Hearts Recalled for Unapproved Epoxy Resin
SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.
- Product
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Category
- Medical Device
- Distribution
- 15 states