Events

Safety Alert for catheters for interventional radiology and diagnostic Balt catheters

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

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
    R1705-185
  • Event Number
    2008DM-0001773-R1
  • Date
    2017-05-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 importer informs that the health agency of france (ansm) 1, has suspended the manufacture, importation and commercialization of the referenced devices, due to the fact that the manufacturer has made changes in the composition of the plastic with which the device is manufactured and has been commercialized before obtaining the approval by the ansm, this change could lead to the presentation of adverse events on the patients.

Device

catheters for interventional radiology and diagnostic Balt catheters
  • Model / Serial
  • Product Description
    For interventional neurology and diagnosis.
  • Manufacturer
    Balt Extrusion

Manufacturer

Balt Extrusion