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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
FDA Recall
Terminated
·SynCardia Systems Inc.·Product code LOZ·August 6, 2015
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
FDA Recall
Terminated
·SynCardia Systems Inc.·Product code LOZ·October 21, 2016