Events

Recall of HEART VENT CATHETER ATRIAL

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
    49929
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-14
  • 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 identified a potential patient safety risk which may occur during the use of venting catheters. the malleable stylet which aids during insertion of the vent catheter is coated with a white plastic. the white plastic on the stylet has the potential to become damaged through interaction with the hard plastic suction adapter on the vent catheter. this can result in the disruption of the white plastic coating on the stylet. there is an increased chance of generating particulate if he stylet is withdrawn with sharp bends and/or reinserted into the vent catheter. reinsertion may lead to an increased potential for particulate to enter the vasculature. no injury has been associated with the use of this device. as a result edwards is adding warnings to the instructions for use included with the affected device models.

Device

HEART VENT CATHETER ATRIAL
  • Model / Serial
    Model Catalog: E060 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: PE062 (Lot serial: ALL LOTS WITHIN EXPIRY); Model Catalog: E061 (Lot serial: ALL LOTS WITHIN EXPIRY)
  • Product Description
    HEART VENT CATHETER ATRIAL
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.