Events

Safety Alert for intra aortic balloon catheters

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

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
    I1606-246
  • Event Number
    2014DM-0002993-R1
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 states that it has identified that the referenced devices have been packaged with instructions for incorrect use and belonging to another device, which can lead to confusion for users and potentially serious adverse events on the patient.

Device

intra aortic balloon catheters
  • Model / Serial
    SENSATION PLUS 8FR and SENSATION PLUS 7.5FR, lots 3000001484 up to 3000024495.
  • Product Description
    They are used for aortic counterpulsation therapy, by means of inflation of the balloon during diastole and deflation during systole, it increases the blood supply to the heart muscle and decreases the work of the left ventricle.
  • Manufacturer
    Datascope Corp

Manufacturer

Datascope Corp
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA