Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Bionics Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29687
  • Event Risk Class
    Class 2
  • Event Number
    Z-1332-04
  • Event Initiated Date
    2004-07-27
  • Event Date Posted
    2004-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34355
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, Cochlear - Product Code MCM
  • Reason
    Battery pack may overheat and cause patient burns.
  • 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

Device

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

Manufacturer

Advanced Bionics Corporation
  • Manufacturer Address
    Advanced Bionics Corporation, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Source
    USFDA