Events

Recall of EDWARDS COMMANDER DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EDWARDS LIFESCIENCES (CANADA) 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
    62231
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-13
  • 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 balloon lock mechanism on the handle of the edwards commander delivery system may not fully engage to the balloon catheter during the fine adjustment part of the alignment procedure. this has the potential to result in the inability to position the valve between the valve alignment markers. deploying the valve when it is not between the valve alignment markers may result in suboptimal valve deployment.

Device

EDWARDS COMMANDER DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 9610TF29 (Lot serial: ALL); Model Catalog: 9610TF20 (Lot serial: ALL); Model Catalog: 9610TF23 (Lot serial: ALL); Model Catalog: 9610TF26 (Lot serial: ALL)
  • Product Description
    EDWARDS COMMANDER DELIVERY SYSTEM
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.