Skip to content
Recall Observatory FDA recall evidence

Device product

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

Z-0659-2017

October 21, 2016

Class I

Product summary

Firm
SynCardia Systems Inc.
Event
Event 75600
Status
Terminated
Classification
Class I
Quantity
5
Official record key
device-enforcement:Z-0659-2017

Official wording

Reason: 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.

Code information: S/N 5002  UDI (01)00858000003121(21)5002 S/N 5005  UDI (01)00858000003121(21)5005 S/N 5008  UDI (01)00858000003121(21)5008 S/N 5009  UDI (01)00858000003121(21)5009 S/N 5010  UDI (01)00858000003121(21)5010

Distribution pattern: US distribution to Virginia and Arizona.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.