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
September 23, 2015 /3BL Media/ - 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.”