Events

Safety Alert for Temporary Total Artificial Heart System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Syncardia Systems. 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
    I1801-74
  • Event Number
    2016EBC-0014444
  • Date
    2018-01-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=57
  • 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

Temporary Total Artificial Heart System
  • Model / Serial
    Freedom console reference 595000-001
  • Product Description
    The TAH-T temporary total artificial heart system is indicated as a bridge to cardiac transplantation in patients who are eligible due to the risk of imminent death due to biventricular failure. The total-temporal artificial heart is indicated in eligible transplant patients at risk of imminent death due to biventricular terminal failure. Persistent ventricular tachycardia, refractory cardiogenic shock, rejection of the biological heart transplant, cardiac amyloidosis, congenital heart conditions. The TAH-T system is designed for use in hospital during and after the surgical implantation of the TAH-T. The Freedom driver system used with 50cc and 70cc TAH-T is designed for intrahospital and extrahospital use. The TAH-T system with the Freedom driver system is indicated for use as a translational bridge in patients who are candidates for heart transplantation in whom the TAH-T has been implanted and are clinically stable.
  • Manufacturer
    Syncardia Systems. Inc.

Manufacturer

Syncardia Systems. Inc.