Class II — SynCardia Systems LLC
| Recalling firm | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Registered facility | SYNCARDIA SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. |
| Product | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO |
| Quantity | 114 units |
| Distribution | US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia |
| Initiated | 2023-08-01 |
| Classified | 2023-10-20 |
| Recall number | Z-0126-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SynCardia Systems LLC (Z-0126-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92930/
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