Events

Recall of ZENITH RENU AAA CONVERTER WITH H&L-B ONE-SHOT INTRODUCER 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
    32788
  • Event Risk Class
    II
  • Event Initiated Date
    2009-03-17
  • 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
    In rare cases the trigger wire can become damaged and then compressed between the stent and the top cap making it difficult to remove.

Device

ZENITH RENU AAA CONVERTER WITH H&L-B ONE-SHOT INTRODUCER SYSTEM
  • Model / Serial
    Model Catalog: AX1-2-22-113 (Lot serial: all); Model Catalog: AX1-1-36-99 (Lot serial: all); Model Catalog: AX1-1-36-133 (Lot serial: all); Model Catalog: AX1-1-36-116 (Lot serial: all); Model Catalog: AX1-1-32-125 (Lot serial: all); Model Catalog: AX1-1-32-91 (Lot serial: all); Model Catalog: AX1-1-32-108 (Lot serial: all); Model Catalog: AX1-1-30-91 (Lot serial: all); Model Catalog: AX1-1-30-125 (Lot serial: all); Model Catalog: AX1-1-30-108 (Lot serial: all); Model Catalog: AX1-1-28-91 (Lot serial: all); Model Catalog: AX1-1-28-125 (Lot serial: all); Model Catalog: AX1-1-28-108 (Lot serial: all); Model Catalog: AX1-1-26-91 (Lot serial: all); Model Catalog: AX1-1-26-125 (Lot serial: all); Model Catalog: AX1-1-26-108 (Lot serial: all); Model Catalog: AX1-1-24-91 (Lot serial: all); Model Catalog: AX1-1-24-125 (Lot serial: all); Model Catalog: AX1-1-24-108 (Lot serial: all); Model Catalog: AX1-1-22-91 (Lot serial: all); Model Catalog: AX1-1-22-125 (Lot serial: all); Model Catalog: AX1-1-22-108 (Lot serial: al
  • Product Description
    zenith renu aaa converter
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.