Events

Recall of Thermocool Smarttouch SF Bi-Directional Navigation 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-2017-RN-01208-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01208-1
  • 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 manufacturer biosense webster has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for two specific lots of thermocool brand catheters. alert 402 implies a ‘map: magnetic distortion’ when connected to carto 3 system. magnetic distortion may result in inaccurate catheter tip location information on the carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy. severe complications (e.G. av block, vascular injury, cardiac perforation) are highly unlikely but may occur due to the physician selecting higher than required power settings for a given anatomical area.Whilst there have been no reports of adverse events in australia, one adverse event of pericardial effusion requiring pericardiocentesis with no further patient consequences was reported internationally, and was deemed to be potentially associated with this issue.
  • Action
    1. Users should immediately inspect the device(s) in possession to determine if they hold affected product, if so quarantine this product prior to returning it to J&J; Medical. 2. Complete and return the supplied acknowledgement form, even if no affected product is present, as directed. 3. Return any affected product within 30 business days, by contacting JJM Customer Service on 1800 252 194. 4. Forward this notice to relevant personnel. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable). 5. Maintain awareness of this notice.

Device

Thermocool Smarttouch SF Bi-Directional Navigation Catheter
  • Model / Serial
    Thermocool Smarttouch SF Bi-Directional Navigation CatheterProduct Number: D134805Lot Numbers.: 17682911L and 17685902LARTG Number: 233355
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd