Class II — SynCardia Systems Inc.
| Recalling firm | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Registered facility | SYNCARDIA SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning. |
| Product | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. |
| Quantity | 81 units |
| Distribution | Worldwide Distribution -- US (nationwide) |
| Initiated | 2012-12-05 |
| Classified | 2012-12-28 |
| Terminated | 2013-06-07 |
| Recall number | Z-0620-2013 |
| 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 Inc. (Z-0620-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63915/
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