Events

Recall of Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cochlear Ltd.

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
    RC-2014-RN-00452-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00452-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The cochlear baha soft tissue gauge, part #95070 may have a manufacturing imperfection in the smooth surface of the metal. while this imperfection is minimal, cochlear's risk analysis has indicated that it could potentially leave residual metal on the patient’s skin. to date there have been no adverse events reported to cochlear associated with the use of this instrument.
  • Action
    Cochlear will remove and replace current Soft Tissue Gauge with an unaffected instrument as quickly as possible. This new instrument has passed additional inspection under microscope to ensure it is not affected by this issue. The instruments removed from the field will also be subjected to the additional inspection under microscope and, if unaffected, be returned for use as required. Any instruments failing additional inspection under microscope will be scrapped. There is no change to clinical management guidelines for patients who have had implant surgery using this instrument.

Device

Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)
  • Model / Serial
    Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit) Part Number: 95070ARTG Number: 205705
  • Manufacturer
    Cochlear Ltd

Manufacturer

Cochlear Ltd