The United States Food and Drug Administration (FDA) has issued an alert concerning Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t). The affected products were manufactured from 3 November 2014 to 29 July 2015 and distributed from 10 November 2014 to 29 July 2015. The affected lot numbers and serial numbers are identified as follows:
The manufacturer is recalling the affected products as a specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advanced warning that the device may fail. If it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound. However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver.
For details, please refer to the FDA websites:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm463300.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm463318.htm
The manufacturer is now replacing the affected drivers with new ones. If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 September 2015