Safety Alert for counterpulsation equipment

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
    R1709-432
  • Event Number
    2007EBC-0000973
  • Date
    2017-09-13
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 it has been able to identify that there is a risk of a valve failure that prevents the balloon from inflating and deflating properly, leading to the occurrence of possible serious adverse events on the patients.

Device

  • Model / Serial
    CS100i – CS100 - CS300
  • Product Description
    Cardiac aid device to inflate and deflate intra-aortic balloons, allowing temporary support of the left ventricle through the principle of counterpulsation.
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NIDFSINVIMA