SynCardia Systems Inc.: Medical Device Recall in 2016 - (Recall #: Z-0659-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: October 21, 2016

Date Posted: December 14, 2016

Recall Number: Z-0659-2017

Event ID: 75600

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5

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.

Voluntary or Mandated:

Voluntary: Firm initiated