Events

Recall of ThermoCool SF NAV Catheter Family

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-2014-RN-00588-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00588-1
  • 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
    Due to a higher frequency of reported adverse events related to cardiac perforations and atrio-esophageal fistula johnson & johnson medical is updating the ifu to include the following information:- verify that the catheter selection knob on the compatible rf generator is on the “tcool sf” or thermocool sf similar option and ensure that the maximum temperature is set at 40°c- do not rely on electrode temperature rise to determine if tissue heating is occurring during rf energy delivery as bench and animal studies showed no significant electrode temperature rise during rf ablation.J & j is also providing information to reinforce procedural steps and precautions set out in the ifu.
  • Action
    J & J is notifying their customers of additional information included in the IFU: - Verify that the CATHETER SELECTION KNOB on the compatible RF generator is on the “Tcool SF” or Thermocool SF similar option and ensure that the maximum temperature is set at 40°C - Do not rely on electrode temperature rise to determine if tissue heating is occurring during RF energy delivery as bench and animal studies showed no significant electrode temperature rise during RF ablation. J & J is also providing information to reinforce procedural steps and precautions set out in the IFU.

Device

ThermoCool SF NAV Catheter Family
  • Model / Serial
    ThermoCool SF NAV Catheter FamilyProduct Codes: BNI35DDCT, BNI35FFCT, BNI35JJCT, BNI35FJCT, BNI35DFCT, BNI35BBCT, BNI35BDCT, BNI35BFCT, BNI35DJCT, BNI35DDH, BNI35FFH, BNI35JJH, BNI35FJH, BNI35DFH, BNI35BBH, BNI35BDH, BNI35BFH, BNI35DJHARTG Number: 178843
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd