Events

Recall of Cochlear Baha Soft tissue gauge

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

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
    68080
  • Event Risk Class
    Class 2
  • Event Number
    Z-1699-2014
  • Event Initiated Date
    2014-04-09
  • Event Date Posted
    2014-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126911
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Reason
    Cochlear america is recalling cochlear baha soft tissue gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.
  • Action
    Customers were notified via letter on 4/17/14. This communication included an explanation of the recall and instructions to quarantine and return products.

Device

Cochlear Baha Soft tissue gauge
  • Model / Serial
    Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Cochlear Baha Soft tissue gauge 6mm. || Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
  • Manufacturer
    Cochlear Americas Inc.

Manufacturer

Cochlear Americas Inc.
  • Manufacturer Address
    Cochlear Americas Inc., 13059 E Peakview Ave, Centennial CO 80111-6511
  • Manufacturer Parent Company (2017)
    Cochlear Ltd.
  • Source
    USFDA