Events

Safety Alert for Carotid Stent System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Cordis Europa N.V || Cordis Corporation.

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
    R1605-212
  • Event Number
    2012DM-0000902-R1
  • Date
    2016-05-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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 determined that the products manufactured between april 27, 2015 and november 22, 2015, have been associated with an increase in the frequency of incidents of difficulty of deployment and in some cases of separation of the axis of the external member which results in the inability to deploy or its partial deployment, leading to the occurrence of adverse events on patients.

Device

Carotid Stent System
  • Model / Serial
    PRECISE PRO RX / PCxxyyXCE, specific lots.
  • Product Description
    Carotid stents are indicated for use in patients with stenotic lesions of the carotid artery (s).
  • Manufacturer
    Cordis Europa N.V || Cordis Corporation

Manufacturer

Cordis Europa N.V || Cordis Corporation