Events

Recall of Device Recall Harmony HiResolution Bionic Ear system

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

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
    52700
  • Event Risk Class
    Class 2
  • Event Number
    Z-2039-2009
  • Event Initiated Date
    2009-06-10
  • Event Date Posted
    2009-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83675
  • 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
    The recall was initiated after advanced bionics became aware of fourteen (14) devices manufactured between may 27, 2005 and june 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. these devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. patients with these devices may experience a decreas.
  • Action
    Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.

Device

Device Recall Harmony HiResolution Bionic Ear system
  • Model / Serial
    Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, Canada, France and South Korea.
  • Product Description
    Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. || Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
  • Manufacturer
    Advanced Bionics LLC

Manufacturer

Advanced Bionics LLC
  • Manufacturer Address
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Manufacturer Parent Company (2017)
    Sonova Holding Ag
  • Source
    USFDA