FDA Issues Class I Recall of Syncardia Freedom Driver
The U.S. Food and Drug Administration (FDA) issued on Sept. 22 a Class I recall of certain SynCardia Systems Total Artificial Heart Freedom Drivers, indicating that use of this device has a high risk of adverse events or death.
The Freedom Driver system is intended to operate and monitor the mechanical heart replacement, replacing left and right ventricle function. However, the FDA has found that the driver has the potential to fail, causing the heart replacement device to stop working.
The Agency notes that there is no advance warning of device failure, but an alarm will sound after failure occurs. Patients will lose consciousness immediately and are at risk of serious injury or death.
Syncardia issued a voluntary recall in early August and states that the affected units have been replaced. The affected units include lot number 85978, with serial numbers 85978-001 through 85978-040, and lot number 85979, with serial numbers 85979-001 through 85979-040.
Clinical Topics: Cardiac Surgery
Keywords: Equipment Failure, Heart Ventricles, Heart, Artificial, Prostheses and Implants, United States Food and Drug Administration, Ventricular Function, Right
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