Companion External Battery — Class II medical device recall Z-0620-2013
Terminated recall by SynCardia Systems Inc., reported 2013-01-09, distributed nationwide. Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver System becaus
| Recall number | Z-0620-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SynCardia Systems Inc., Tucson, AZ, United States |
| Recall initiated | 2012-12-05 |
| Classified | 2012-12-28 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 81 units |
| Lot numbers | 00067, 00068, 00069, 00070, 00071, 00072, 00073, 00075, 00076, 00077, 00078, 00079, 00080, 00081, 00082, 00083, 00084, 00085, 00086, 00087, 00088, 00089, 00090, 00091, 00092, 00093, 00094, 00095, 00096, 00097, 00098, 00099, 00100, 00101, 00102, 00103, 00104, 00105, 00106, 00107 and 43 more |
| Serial numbers | 00067, 00068, 00069, 00070, 00071, 00072, 00073, 00075, 00076, 00077, 00078, 00079, 00080, 00081, 00082, 00083, 00084, 00085, 00086, 00087, 00088, 00089, 00090, 00091, 00092 and 58 more |
| Model numbers | 293001-001 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0620-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.