Recall Z-0620-2013 ยท DSZ Pacemaker Battery
SynCardia Systems Inc.
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.
| Date | Dec 28, 2012 (initiated Dec 5, 2012) |
| 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. |
| Root cause | Process control |
| Action | Syncardia Systems sent a" Urgent Field Safety Notice" dated December 10, 2012, to all affected customers. The letter identified the product the problem and what action the customer needs to take.. The letter informed the customers that there were 3 reported thermal battery events (2 of which occurred on-site at either SynCardia or at the battery manufacturer, Dow Kokam, and one incident that occurred in the field) which caused physical damage to the batteries including burning and/or charring. The batteries were not in use with a patient at time of the reported issue, and there were no rep |
| Quantity | 81 units |
| Distribution | Worldwide Distribution -- US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.