Events

Safety Alert for SMARTFLEX Vascular Stent Systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Burpee Materials Technology Llc, Usa || Cordis Cashel, Irlanda.

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
    I1802-84
  • Event Number
    2015DM-0012719 ; 2015DM-0013114
  • Date
    2018-02-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=56
  • 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

Device

SMARTFLEX Vascular Stent Systems
  • Model / Serial
    SF05080MV, SF05150SV, SF06030MV, SF06040MV, SF06060MV
  • Product Description
    The stent is indicated for use in the primitive and external iliac arteries to improve luminal diameters in patients with stenosis and occlusive symptomatic vasculopathies.
  • Manufacturer
    Burpee Materials Technology Llc, Usa || Cordis Cashel, Irlanda

Manufacturer

Burpee Materials Technology Llc, Usa || Cordis Cashel, Irlanda
  • Source
    NIDFSINVIMA