Events

Recall of FEM-FLEX II FEMORAL ARTERIAL 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
    76876
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-10
  • 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 received five complaints in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16 18 and 20 french. some of the reported events involved separation of the tip of the dilator and required retrieval through an interventional radiologic procedure.

Device

FEM-FLEX II FEMORAL ARTERIAL CANNULA
  • Model / Serial
    Model Catalog: FEMII020A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII018AS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII018A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII016AS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII016A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FEMII020AS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DIIFEMII016A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DIIFEMII018A (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DIIFEMII020A (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    FEM-FLEX II FEMORAL ARTERIAL CANNULA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.