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SynCardia Systems Inc. recalls 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-00
Recalled December 14, 2016 · FDA recall Z-0659-2017 · SynCardia Systems
Hazard
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function. · FDA Class I
Units
5
Sold at
US distribution to Virginia and Arizona.
Description
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.
Product
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Manufacturer(s)
SynCardia Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →