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

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
  • Event ID
  • Event Risk Class
  • Event Initiated Date
  • Event Country
  • Event Source
  • 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
    Because of a lack in strength of the material it could happen that the hydrophilic-coated pebax tip gets loose from the core of the guidewire. in this case some fragments of the tip of the guidewire could get loose and stay in the body of the patient. this would have another surgery required to remove the parts of the guidewire from the body. this problem occured only once in a hospital in kufstein austria. for these products some of the guidewires from this batch could have the same problem.


  • Model / Serial
    Model Catalog: UAS-35150-S (Lot serial: C15-4089); Model Catalog: UAS-35150-S (Lot serial: G4918166); Model Catalog: UAS-35150-S (Lot serial: G4905791)
  • Product Description
  • Manufacturer