Events

Recall of Biosense Webster nMARQ Circular Irrigated 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
    18785
  • Event Initiated Date
    2015-07-02
  • 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 received an increased number of complaints related to a low temperature measurement anomaly at electrodes of the nmarq® circular irrigated catheter., during the same time period, has also received three reports of deaths of patients who were treated with the nmarq® circular irrigated catheter. two of these cases were confirmed to be caused by atrio-oesophageal fistula., no direct link could be confirmed between the low temperature issue and the atrio-oesophageal fistula as it was detected in only one of the two confirmed cases. therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation.As a result of these issues, biosense webster is recalling the nmarq® circular irrigated catheter and is conducting a full investigation.
  • Action
    Product to be returned to supplier

Device

Biosense Webster nMARQ Circular Irrigated Catheter

Manufacturer

Biosense Webster Inc