SynCardia Systems LLC Recall 92930
Description: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC Recall 92930 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0126-2024 |
| Event ID | 92930 |
| Event Description | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO |
| Product Type | Devices |
| 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 |
| Quantity | 114 units |
| Recall Reason | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. |
| Device Classification | 20231101 |
| Device Code Info | All Lots/ UDI: 00858000003053 |
| Center Classification Date | 20231020 |
| Recall Initiation Date | 20230801 |
| Recalling Firm | SynCardia Systems LLC |
| Initial Notification | Letter |
| Similar To |