FDA issues Class I recall of Syncardia Freedom driver

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The FDA has issued a Class I recall of a select number of SynCardia Systems Total Artificial Heart Freedom driver.

A Class I recall, the most serious type of recall, indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The mechanical heart replacement is implanted to replace left and right ventricle function, and the Freedom Driver system is attached to the pump to operate and monitor the device.

A specific part of the Freedom  Driver mechanism may fail and cause the device to stop pumping, according to the FDA. Patients who experience the driver failures do not receive any advanced warning of the failure but a red light and loud continuous alarm that sound after the failure.

If the part fails and the pump stops, the patient will lose consciousness almost immediately, the FDA said, making the alarm useless. If not switched to a backup driver quickly, the patient could experience serious injury or death, the agency said.

Following the FDA’s announcement of the recall, SynCardia issued a statement to provide an update. The company said it initiated the voluntary recall Aug. 6 after discovering the malfunction was caused by an unauthorized rework of a component by a supplier. The patient involved in the initial incident that prompted the recall briefly lost consciousness when his pump stopped, but a caregiver was able to swtich to a backup driver and the patient sustained no permanent injury, according to the company.

SynCardia said it worked with the supplier to resolve the issue and notified all centers that had the potentially affected units at the same time the FDA was notified.

All potentially affected units were replaced by Aug. 14, according to the company.

Twenty-nine units, manufactured between November 3, 2014 and July 29, 2015, and distributed between November 10, 2014 and July 29, 2015, are being recalled. 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.

Access the  recall.