The SynCardia Total Artificial Heart (TAH-t) is a mechanical replacement for a patient’s heart. It is a pump that is implanted into the chest to replace the bottom half of a patient's heart (left and right ventricles). The device is sewn to the remaining top half of the patient's heart (atria). The Freedom Driver System is attached to the TAH-t pump and operates and monitors the device. The TAH-t is used in patients at risk of imminent death from heart failure who are waiting for a heart transplant.
The reason for the recall is that 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.
On August 6, 2015, SynCardia Systems of Tucson, AZ sent an Urgent: Medical Device Recall letter to their customers. SynCardia told customers they will notify all hospitals that have the affected drivers and replace the drivers with new ones. The two lot numbers of the defective Freedom Driver Systems are 85978 (Serial Numbers 85978-001 through 85978-040) and 85979 (Serial Numbers 85979-001 through 85979-040). These were manufactured and distributed between November 2014 and July 2015.
See the Recall
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues