FDAOctober 21, 2016device
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
syncardia systemssyncardia
UPCs
00858000003121
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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