Events

Recall of EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE WITH THE ASCENDRA+ DELIVERY SYSTEM AND ACCESSORIES (TRANSAPICAL APPROACH)

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
    69006
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-21
  • 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
    Individual valves contained indications different than those authorized in the issuance of device license.

Device

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE WITH THE ASCENDRA+ DELIVERY SYSTEM AND ACCESSORIES (T...
  • Model / Serial
    Model Catalog: 9355AS326 (Lot serial: na); Model Catalog: 9355AS329 (Lot serial: na); Model Catalog: 9355AS323 (Lot serial: na); Model Catalog: 9355NF29 (Lot serial: na); Model Catalog: 9355NF26 (Lot serial: na); Model Catalog: 9355NF23 (Lot serial: na)
  • Product Description
    SAPIEN XT TRANSCATHETER with ascendra delivery system
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.