Events

Recall of GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (SETS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC PERCUSURGE.

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
    19899
  • Event Risk Class
    I
  • Event Initiated Date
    2001-03-16
  • 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
    Due to the application of silicone on the proximal end of the guardwire the adapter may not be able to open and/or close the guardwire extension.

Device

GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (SETS)
  • Model / Serial
    Model Catalog: (Lot serial: ALL LOT NUMBERS)
  • Product Description
    GUARDWIRE
  • Manufacturer
    MEDTRONIC PERCUSURGE

Manufacturer

MEDTRONIC PERCUSURGE
  • Manufacturer Address
    SUNNYVALE
  • Source
    HC