Events

Safety Alert for Catheter with Silicon Balloon GYNECARE THERMACHOICE III

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Gynecare Inc, A Division Of Ethicon, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1603-92
  • Event Number
    2009EBC-0003806
  • Date
    2016-03-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer informs that after careful consideration has taken the decision to discontinue the worldwide commercialization (sales, distribution and promotion) of the components, controller and umbilical cable of the gynecarethermachoice® iii uterine therapy balloon system, this product will not be returned to the market.

Device

Catheter with Silicon Balloon GYNECARE THERMACHOICE III
  • Model / Serial
  • Product Description
    Indicated to remove the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive hemorrhage) due to benign causes and who have completed the gestational phase.
  • Manufacturer
    Gynecare Inc, A Division Of Ethicon, Inc.

Manufacturer

Gynecare Inc, A Division Of Ethicon, Inc.