Every recall we track for SynCardia Systems LLC — 2 in all — plus the complaints and injury reports the public filed about them.
SynCardia recalls 50cc TAH-t artificial hearts with unapproved epoxy resin. This poses a risk of serious injury if not corrected by FDA review. Affected units have specific lot numbers.
SynCardia recalls two models of total artificial heart systems due to reported tears in the cannula from wear and tear stress. Affected units may need repair or replacement.
