SynCardia Systems Artificial Heart Recalled
SynCardia Systems and the U.S. Food and Drug Administration (FDA) have announced a recall of the company’s ‘Total Artificial Heart’ due to its ‘Freedom Driver’ pump system being vulnerable to failing.
About the Artificial Heart Recall
According to MassDevice, the Total Artificial Heart is implanted in the chest in order to replace heart pumping functions. This recall is due to the device’s ‘Freedom Driver’ system having a part which is prone to failure.
If this failure occurs, the device will cease functioning immediately, exposing the patient to potential serious injury and death.
Description of Recalled Ventilators
- The recall encompasses 29 units.
- The units were manufactured between November 3rd 2014 and July 29 2015
- The units are from lot number 85978, with serial numbers 85978-001 through 85978-040, and lot number 85979, with serial numbers 85979-001 through 85979-040
Potential Concern of the Recalled Device
The device gives no warning that is about to shutdown, and, according to the FDA, a patient will pass out almost immediately after the system fails, making the system’s auxiliary alarms useless.
The FDA has classified this as a ‘Class I’ product recall. A Class I recall is “the most serious type of recall” and “involve(s) situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death”.