FDA Medical Device Recalls (openFDA)
Advanced Bionics Corporation: Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
- Recall number
- Z-1332-04
- Recalling firm
- Advanced Bionics Corporation
- Product
- Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
- Status
- Terminated
- Initiated
- 2004-07-27
- Posted
- 2004-08-10
- Terminated
- 2012-03-23
- 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
- Lot, serial or model codes
- All Codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCM
- Firm FEI
- 1000220815
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28