SynCardia Recalls Defective Heart Pump Due to Faulty Driver
Last month, the U.S. Food and Drug Administration (FDA) announced a recall for a defective cardiac device manufactured by SynCardia Systems.
The product in question is the Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t). The TAH-t is a mechanical replacement for a patient's heart that is implanted in the chest, just under the atria. Twenty-nine devices are subject to the recall.
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.
Only two lots of the product are subject to the recall: lot 85978 (serial numbers 85978-001 through 85978-040) and lot 85979 (serial numbers 85979-001 through 85979-040). These units were distributed from November 10, 2014 to July 29, 2015.
On August 6, 2015, SynCardia released an urgent medical device recall to their customers. The company told customers they will notify all hospitals that have the affected drivers and replace the drivers with new ones.
Consumers with questions can contact SynCardia at (866) 480-1122, extension 1308.