Events

Recall of VAGINAL STENT INFLATABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COLOPLAST CANADA CORPORATION.

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
    46551
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-15
  • 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
    The ec certificate of all medical devices from the manufacturer silimed who is a subcontractor to coloplast has been temporarily suspended by their notified body due to particles found at the surface of some breast implants. there is no indication that these issues would pose a threat to the implanted person's safety. the suspension also affects vaginal stents placed on the market by coloplast. in line with recommendations from the authorities coloplast request that all affected devices with silimed as point of origin should be put in quarantine and that use of these devices should be ceased until further notice.

Device

VAGINAL STENT INFLATABLE
  • Model / Serial
    Model Catalog: VS3026 (Lot serial: ALL); Model Catalog: VS3022 (Lot serial: ALL); Model Catalog: VS3024 (Lot serial: ALL); Model Catalog: VS3020 (Lot serial: ALL)
  • Product Description
    VAGINAL STENT - INFLATABLE
  • Manufacturer
    COLOPLAST CANADA CORPORATION

Manufacturer

COLOPLAST CANADA CORPORATION
  • Manufacturer Address
    CONCORD
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    HC