Recall Z-1332-04 ยท MCM Implant, Cochlear
Advanced Bionics Corporation
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
| Date | Aug 10, 2004 (initiated Jul 27, 2004) |
| Status | Terminated |
| Reason | Battery pack may overheat and cause patient burns. |
| Root cause | Other |
| Action | Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005 |
| Quantity | 2458 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.