Events

Recall of NOVAFLEX DELIVERY SYSTEM

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
    83456
  • Event Risk Class
    I
  • Event Initiated Date
    2011-05-05
  • 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 inability to articulate the novaflex delivery system may lead to procedural complications including vessel perforation and potentially patient death. due to a change in manufacturing processes instituted at edwards in august 2010 there are reasonable grounds that all novaflex units manufactured after this date will function as intended. although it is believed the likelihood that other units have been impacted is very low edwards is recalling all novaflex delivery systems manufactured before august 2010 in order to eliminate this risk.

Device

NOVAFLEX DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 9350FS23 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9350FS26 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    NOVAFLEX DELIVERY SYSTEM
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.