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August 7, 2015: Artificial Heart Pump Device Recall Due to Fatal Mechanism Flaw

Artificial Heart Pump Device Recall News

According to an August 7, 2015 Medical Device Safety Alert from the U.S. Food and Drug Administration, SynCardia Systems initiated a recall of the Freedom Driver Systems, a mechanism within an artificial heart pump that operates and monitors the device. This artificial heart pump device recall was spurred by a flaw in the mechanism that could cause the artificial heart pump to stop without warning.

In this case, a warning light on the device will stay red and a loud continuous alarm will sound; unfortunately, once the heart pump stops operating, the patient will almost immediately lose consciousness. Unless a caretaker hears the alarm, the patient will likely be seriously injured or die.

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Artificial Heart Pump Device Recall Details

In the U.S. 29 devices have been recalled.
The effected devices were manufactured from November 3, 2014 to July 29, 2015.
They were distributed from November 10, 2014 to July 29, 2015.

Lot numbers of recalled devices are as followed:
o 85978 (Serial Numbers 85978-001 through 85978-040)
o 85979 (Serial Numbers 85979-001 through 85979-040)

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