[Recalled] SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO — Artificial hearts contain a epoxy resin that has not been reviewed by the FDA f… | FDA 2023-08-01
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO |
|---|---|
| Brand / manufacturer | SynCardia Systems LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0126-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 August 2023 |
| EAN / barcode | 00858000003053 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from SynCardia Systems LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.