Events

Safety Alert for balloon dilatation catheters

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Productos para el Cuidado de la Salud || Futurematrix Interventional || C.R. Bard, Inc || Atrion Medical Products, 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
    I1611-529
  • Event Number
    2014DM-0011068
  • Date
    2016-11-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=113
  • 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 reports that the referenced device may have a 30fr sheath in place of the 24frappropriate sheath, this situation could be detected by the surgical staff and would result in prolongation of the intervention time while the device is changed accordingly, leading to the potentially increase the risk of presenting adverse events on the patient.

Device

balloon dilatation catheters

Manufacturer

Productos para el Cuidado de la Salud || Futurematrix Interventional || C.R. Bard, Inc || Atrion ...
  • Source
    NIDFSINVIMA