SynCardia 5000 Series Freedom Drivers Cl II

Company: SynCardia Systems Inc.
Date of Enforcement Report 12/14/2016
Class lI:

PRODUCT

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Recall Number Z-0659-2017

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.

RECALLING FIRM/MANUFACTURER
SynCardia Systems Inc., tuscon, AZ on 10/21/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5

DISTRIBUTION
US distribution to Virginia and Arizona.

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