Events

Recall of Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)

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-2013-RN-00965-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00965-1
  • 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
    Customer complaints reported that the smarttouch catheters were not irrigating correctly during ablation and often resulted in temperature increases and generator shut-off. an internal investigation identified that there is polyimide delamination of the inner lumen surface that can lead to occlusion of the irrigation fluid lumen. insufficient or lack of irrigation (occlusion) can potentially increase the risk of char or thrombus formation at the tip of ablation catheter, which may lead to thromboembolic events, such as stroke.
  • Action
    Customers are asked to quarantine the affected product remaining in the market and return it to Johnson & Johnson Medical Pty Ltd.

Device

Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directiona...
  • Model / Serial
    Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All lots manufactured prior to August 30, 2013ARTG Numbers: 184035 & 198574
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd