Events

Recall of INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

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
    149686
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-08
  • 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 safety risk which may occur during the use of the intraclude intra-aortic occlusion device (icf100) used in cardiopulmonary bypass surgery. edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. some of the reports have also indicated blood leakage in this area. when damage exists blood loss can occur because blood can fill the device between the lumen shaft and the strain rerlief and leak from the area. no injuries or blood transfusions have been reported. in a worst case scenario with no mitigation blood loss can occur during use of the device.

Device

INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.