Events

Recall of THERMACHOICE UTERINE BALLOON THERAPY SYSTEM - SILICONE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    26490
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Ethicon inc. has initiated a recall of all unexpired lots of the gynecare thermachoice iii thermal balloon ablation silicone catheter because stability data does not substantiate the labeled two-year shelf life of the affected product. the recall involves only the catheter component of the gynecare thermachoice iii uterine balloon therapy system.

Device

THERMACHOICE UTERINE BALLOON THERAPY SYSTEM - SILICONE

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.