Events

Recall of CLARION 1.2, Advanced Bionics implantable cochlear stimulator

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

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
    30209
  • Event Risk Class
    Class 2
  • Event Number
    Z-0044-05
  • Event Date Posted
    2004-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35399
  • 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
    All unimplanted clarion and hiresolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
  • Action
    Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.

Device

CLARION 1.2, Advanced Bionics implantable cochlear stimulator
  • Model / Serial
    Unimplanted CLARION 1.2
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    U.S. and Canada and France
  • Product Description
    Advanced Bionics implantable cochlear stimulator CLARION 1.2 || Models || AB-5100L || AB-5100R || AB-5100ML/R (For Export Only) || AB-5100H || AB-5100H-01A
  • Manufacturer
    Advanced Bionics

Manufacturer

Advanced Bionics
  • Manufacturer Address
    Advanced Bionics, 12750 San Fernando Rd, Sylmar CA 91342-3728
  • Source
    USFDA