Events

Recall of Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty 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-2015-RN-01186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01186-1
  • 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
    This product is being removed from the market as stability data does not substantiate the labelled two-year shelf life of affected product.The affected units may fail prematurely before the labelled two-year shelf life. the failure may be manifested by pinhole leak, hexcap crack leak and tri-y manifold crack leak. these types of leakage may potentially result in the abortion of the procedure, temporary thermal injury to the cervix and/or vagina and in some cases additional surgical procedures.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter
  • Model / Serial
    Gynecare Thermachoice III Thermal Balloon Ablation Silicone CatheterProduct Code: TC033All Lots from 31st November 2013 are affectedARTG Number: 97100
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd