Events

Recall of Biosence Webster ThermoCool SmartTouch Bi-directional Navigation 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
    15358
  • Event Initiated Date
    2013-09-12
  • 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
    An investigation identified a defect in the production process which can lead to occlusion of the irrigation fluid lumen. to date, there have been no patient injuries or adverse events reported as a result of this defect.
  • Action
    Product to be returned to supplier

Device

Biosence Webster ThermoCool SmartTouch Bi-directional Navigation Catheter
  • Model / Serial
    Model: Product Code D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603, Affected: All lots
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc