Events

Recall of Balt COPERNIC2L Occlusion Balloon Catheter

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Balt Extrusion SA.

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
    22082
  • Event Initiated Date
    2017-10-20
  • 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: Getz Healthcare Limited, 2/20 Beatrice Tinsley Crescent, Albany, Auckland
  • Reason
    Post market surveillance has identified damages on the catheter tubes which may lead to unexpected inflation and difficult deflation to the balloon duing the contrast liquid injection through the guiding catheter.
  • Action
    Manufacturer to issue advice regarding use

Device

Balt COPERNIC2L Occlusion Balloon Catheter

Manufacturer

Balt Extrusion SA