Safety Alert for neurovascular STRYKER TRASFORM occlusion balloon catheters

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Stryker Neurovascular || Stryker Neurovascular Cork.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected the possibility that the referenced devices were manufactured using a microscopically machined tube that had not been rinsed after the application of a cleaning solution as part of the manufacturing process, leading to its use causing possible adverse events on the patients.


  • Model / Serial
    M003ESC04100, lot 18958702.
  • Product Description
    The neurovascular STRYKER TRASFORM occlusion balloon catheters have been designed for use in neurological and peripheral vasculature for temporary arrest or control of blood flow, treatment of vasospasms and balloon-assisted embolization of intracranial aneurysms.
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source