Events

Recall of Biosense ThermoCool SF Nav Bi-Directional Catheter

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Biosense Webster Inc.

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
    16575
  • Event Initiated Date
    2014-05-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    The manufacturer has revised the procedural steps and precautions set out in the ifu, 1. when using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the carto ep navigations system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade., 2. do not use the temperature sensor to monitor tissue temperature., 3. precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula.
  • Action
    Instructions for use to be updated

Device

Biosense ThermoCool SF Nav Bi-Directional Catheter

Manufacturer

Biosense Webster Inc