Recall archive / FDA device enforcement
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO — FDA record Z-0126-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- SynCardia Systems LLC
- Quantity
- 114 units
- Agency-reported status
- Completed
- Source record identifier
- Z-0126-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Lots/ UDI: 00858000003053 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 1, 2023
- Recall initiation date
- Aug 1, 2023
- Center classification date
- Oct 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.