Events

Recall of Freedom Driver System used with the SynCardia temporary total artificial heart (TAH-t)

According to Republic of Lebanon Ministry of Public Health, this recall involved a device in Lebanon that was produced by SynCardia Systems, inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2015-09-21
  • Event Country
    Lebanon
  • Event Source
    RLMPH
  • Event Source URL
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202015/21-9-2015/Freedom%20Driver%20System.pdf
  • Notes / Alerts
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Extra notes in the data

Device

Freedom Driver System used with the SynCardia temporary total artificial heart (TAH-t)

Manufacturer

SynCardia Systems, inc
  • Source
    RLMPH