SynCardia Provides Update Regarding Voluntary Recall of Potentially Affected Freedom® Portable Drivers
All potentially affected units were removed from the field by August 14, 2015
TUCSON, Ariz., Sept. 22, 2015 /PRNewswire/ -- SynCardia Systems, Inc. today provided an update regarding the resolution of a recent voluntary recall of a limited number of its Freedom® portable drivers, following a related U.S. Food and Drug Administration (FDA) September 18, 2015 recall announcement.
SynCardia had initiated the voluntary recall August 6, 2015 by sending an urgent email to all SynCardia Certified Centers that had the potentially affected units, after notifying the FDA the same day of an incident with one patient. All potentially affected units were replaced by August 14, 2015.
"The patient in the incident that prompted the recall briefly lost consciousness when his primary unit alarmed and stopped pumping, but quickly regained consciousness when his caregiver switched the patient to his backup Freedom® driver. He received his replacement Freedom® drivers and is doing well with no permanent injury," said Michael Garippa, SynCardia CEO and President. "No other incidents were reported."
The FDA announced the recall on September 18, 2015. By then all the units potentially affected by the recall had been removed from the field and quarantined.
In the United States 11 clinical centers caring for 12 patients accounted for 29 potentially affected Freedom® drivers. All units were replaced with unaffected units by August 12, 2015.
In the European Union, seven patients were switched by August 14, 2015.
"The malfunction was caused by an unauthorized rework of a component by a supplier," Garippa says. "The supplier worked quickly with us to identify and resolve the problem."
"We want to thank the FDA for working with us in this action," Garippa says.
For additional information, please visit: http://www.syncardia.com/
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is a medical technology company focused on developing and manufacturing the SynCardia temporary Total Artificial Heart (TAH-t). The SynCardia TAH-t is an implantable system designed to assume the full function of a failed human heart in patients suffering from end-stage biventricular (both sides) heart failure. The SynCardia TAH-t is an implantable system which has served from than 1,470 patients.
The SynCardia TAH-t is the only total artificial heart that is commercially available in the United States, European Union and Canada for use as a bridge to donor heart transplantation.
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SOURCE SynCardia Systems, Inc.