Recall Z-0126-2024— SynCardia Systems LLC
Class II · Completed
Class II FDA medical device recall by SynCardia Systems LLC, initiated 2023-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO. Reason: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy..
- Recalling firm
- SynCardia Systems LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-08-01
- Firm location
- Tucson, AZ, United States
Product description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason for recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.