Events

Safety Alert for Penumbra System

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

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
    R1708-334
  • Event Number
    2010DM-0005690
  • Date
    2017-10-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=70
  • 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 the risk of the supply cord splitting or separating during use, these pieces could be left inside the patient's cerebral bloodstream, these fragments or the attempts made to recover them could have serious consequences, leading to possible events adverse in patients.

Device

Penumbra System
  • Model / Serial
    3D, lots C00644, C00645, C00646, C00717.
  • Product Classification
    Neurological Devices
  • Product Description
    For use in the revascularization of patients with acute ischemic stroke.
  • Manufacturer
    Penumbra Inc.

Manufacturer

Penumbra Inc.