Events

Recall of ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (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
    25582
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-10
  • 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
    Testing demonstrates a process used to manufacture the inner catheter to stylet joint of the delivery system doesn't meet the required specification on a consistent basis and there is a risk the joint may separate during deployment. a failure of this joint would represent a device malfunction and were it to occur during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention or may result in vessel trauma or an embolic event.

Device

ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4265701); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-60 (Lot serial: 4470824); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4020115); Model Catalog: ZIVX5-18-125-9-40 (Lot serial: 4470824)
  • Product Description
    ZILVER VASCULAR STENT WITH RAPID EXCHANGE
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.