Events

Recall of Idoman Thermablate Endometrial Ablation System

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

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
    18469
  • Event Initiated Date
    2015-05-07
  • 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: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    The instructions for use (ifu) of the thermablate endometrial ablation system (eas) has been updated following four case reports of uterine perforation. there is an increased risk of patient injury (including damage to non-targeted tissue) if both thermablate eas procedure and hysteroscopic tubal occlusion/sterilisation are performed on the same day.
  • Action
    Instructions for use to be updated

Device

Idoman Thermablate Endometrial Ablation System
  • Model / Serial
    Model: Product Codes: 22101 & 21004, Affected: All lots
  • Manufacturer
    Idoman Teoranta

Manufacturer

Idoman Teoranta