FDA Device recall Z-0126-2024
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- FDA Device
- Class II
- completed
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO by Syncardia Systems, citing artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0126-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-08-01 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Syncardia Systems |
| Distribution | AZ, CA, FL, IL, IN, NC, NE, NY, OH, OK, PA, TX, VA, WA, WI |
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.
Identifiers
| code_info | All Lots/ UDI: 00858000003053 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0126-2024%22
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