Events

Recall of ESSURE PERMANENT BIRTH CONTROL SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PROVINCIAL MEDICAL SUPPLIES LTD..

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
    39879
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-16
  • 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
    Women who undergo both essure procedure and an endometrial ablation may be at increased risk for certain events known to be associated with each procedure. bayer has chosen to notify consignees of the information.

Device

ESSURE PERMANENT BIRTH CONTROL SYSTEM
  • Model / Serial
    Model Catalog: ESS 305 (Lot serial: All Lots)
  • Product Description
    ESSURE Contraceptive Device for Hysteroscopic Placement;ESSURE PERMANENT BIRTH CONTROL SYSTEM
  • Manufacturer
    PROVINCIAL MEDICAL SUPPLIES LTD.

Manufacturer

PROVINCIAL MEDICAL SUPPLIES LTD.