Events

Recall of EDWARDS TRANSCATHETER MITRAL VALVE REPAIR SYSTEM-GUIDE SHEATH

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
    56052
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-02
  • 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
    An inspection method issue may have affected the inner lumen of the guide sheaths (it is estimated that this can be found in approximately 2% of units). while no complaints or patient adverse events have been reported to the firm it is possible that if used this could lead to the embolization of guide sheath inner lumen material.

Device

EDWARDS TRANSCATHETER MITRAL VALVE REPAIR SYSTEM-GUIDE SHEATH
  • Model / Serial
    Model Catalog: 10000GS (Lot serial: LOT 61130785)
  • Product Description
    EDWARDS PASCAL TRANSCATHETER MITRAL VALVE REPAIR SYSTEM - GUIDE SHEATH
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.