Events

Recall of ASCENDRA BALLOON CATHETER

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
    41872
  • Event Risk Class
    II
  • Event Initiated Date
    2010-03-26
  • 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
    Edwards lifesciences has been made aware of user reports that the loader assembly of the ascendra balloon catheter provided an insufficient seal around the proximal end of the pusher resulting in the leakage of blood during the transapical procedure to deliver the sapien thv transcatheter heart valve (used under special access). edwards lifesciences issued a training bulletin on this subject and has chosen to augment and emphasize the proper use of the loader assembly by way of a field safety notice to increase physician awareness of proper technique.

Device

ASCENDRA BALLOON CATHETER
  • Model / Serial
    Model Catalog: 9100BCL26 (Lot serial: ALL LOTS); Model Catalog: 9100BCL23 (Lot serial: ALL LOTS)
  • Product Description
    ASCENDRA BALLOON CATHETER
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.