Events

Safety Alert for Removable Spirals GUGLIELM GDC

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

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
    I1604-136
  • Event Number
    2012DM-0008975
  • Date
    2016-04-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=148
  • 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 has detected that the incorrect use guidelines, dfu, were included with the product previously referenced, placing the general dfus for gdc, instead of the specific dfus for gdc 360, which could lead to their being presented potentially adverse events on patients.

Device

Removable Spirals GUGLIELM GDC
  • Model / Serial
    M0033471020SR0 and M00334811300
  • Product Description
    Treatment of intracranial aneurysm and other vascular, neurological and peripheral abnormalities such as arteriovenous malformations and fistula-arteriovenous.
  • Manufacturer
    Stryker Neurovascular Cork || Stryker Neurovascular

Manufacturer

Stryker Neurovascular Cork || Stryker Neurovascular
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA