SynCardia Systems Recalling Heart Replacement Device

SynCardia Systems is recalling 29 units of its Total Artificial Heart Freedom, a mechanical replacement for a patient’s heart implanted into the chest to replace the left and right ventricles.

The company recalled the device after it was found that a specific part of the drive mechanism may fail and cause the device to stop pumping without advanced warning.

According to the Class I recall, the patient will lose consciousness almost immediately if the device stops pumping and will experience serious injury or death if not immediately switched to a backup driver.

SynCardia Systems notified customers on Aug. 6 of the recall, and will notify all hospitals that have affected drivers and replace them with new ones. — Michael Cipriano