Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.

FDA device recall Z-1332-04 · posted 2004-08-10 · Terminated

Recall details

Recalling firm

Advanced Bionics Corporation

Reason for recall

Battery pack may overheat and cause patient burns.

Action taken

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

Root cause

Other

Status

Terminated

Product code

MCM

Quantity affected

2458

Distribution

Nationwide and Canada

Date initiated

2004-07-27

Date posted

2004-08-10

Date terminated

2012-03-23

Location

Sylmar, CA