Events

Recall of FEM-FLEX II VENOUS CANNULA

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
    49930
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-26
  • 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
    Through post market surveillance edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula sizes 8 10 and 12 french only. edwards has received one customer complaint regarding a released wire located at the tip area of the cannula which was identified prior to use. although the condition does not affect the functionality of the cannula there is potential patient safety risk if a protruding wire is not detected prior to use.

Device

FEM-FLEX II VENOUS CANNULA
  • Model / Serial
    Model Catalog: FEMII012V (Lot serial: 59873252); Model Catalog: FEMII008A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII008V (Lot serial: 59873252); Model Catalog: FEMII012V (Lot serial: 59849124); Model Catalog: FEMII010V (Lot serial: 59849124); Model Catalog: FEMII008V (Lot serial: 59849124); Model Catalog: FEMII012V (Lot serial: 59796683); Model Catalog: FEMII010V (Lot serial: 59796683); Model Catalog: FEMII008V (Lot serial: 59796683); Model Catalog: FEMII012V (Lot serial: 59723307); Model Catalog: FEMII010V (Lot serial: 59723307); Model Catalog: FEMII008V (Lot serial: 59723307); Model Catalog: FEMII012V (Lot serial: 59890924); Model Catalog: FEMII010V (Lot serial: 59890924); Model Catalog: FEMII008V (Lot serial: 59890924); Model Catalog: FEMII012V (Lot serial: 59849119); Model Catalog: FEMII010V (Lot serial: 59849119); Model Catalog: FEMII008V (Lot serial: 59849119); Model Catalog: FEMII012V (Lot serial: 59751074); Model Catalog: FEMII010V (Lot serial: 59751074); Model Catalog: FEMII008V (Lo
  • Product Description
    FEM-FLEX II VENOUS CANNULA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.