Class 1 Device Recall SynCardia Freedom Driver System

• Date Initiated by Firm: October 21, 2016
• Create Date: December 08, 2016
• Recall Status: Terminated on February 21, 2017
• Recall Number: Z-0659-2017
• Recall Event ID: 75600
• PMA Number: P030011
• Product Classification: Artificial heart - Product Code LOZ
• Product: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
• 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
• Recalling Firm/ Manufacturer: SynCardia Systems Inc.; 1992 E Silverlake Rd; Tucson AZ 85713-3865
• For Additional Information Contact: 520-545-1234
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: On 10/21/16 customers were notified by phone. Customers were informed that patients who were being supported by affected Drivers must be switched to unaffected Drivers. The firm will provide unaffected Freedom Drivers to replace the affected Drivers. Affected Drivers must be return to the firm. Instructions for return provided, and Acknowledgment Form must be completed. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, LLC 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time Hotline 24/7 866-771-9437 www.syncardia.com On 10/27/16 customer notification letters were sent. The letter provided instructions on how to recognize the device could fail. The patient and caregiver will recognize that an affected Driver is failing because the Freedom Driver will stop pumping without generating any sound or any visual or audible alarms. When functioning, the Freedom Driver exhibits a distinctive pumping sound; when it stops pumping the lack of sound is noticeable. Generally, if the Freedom Driver function is interrupted, a visual and/or audible alarm will occur. However, as a result of this component failure, when affected Freedom Drivers stop functioning, there will be no visual or audible alarms, and no pumping sound. Actions to Be Taken by The Customer/User SynCardia has provided unaffected Freedom Drivers to the two hospitals to replace the affected 5000 series Drivers. All patients with affected Freedom Drivers have undergone the exchange and received unaffected Drivers. The hospitals have returned all the affected Freedom Drivers to SynCardia. The hospitals are requested to complete the Recall Acknowledgement and Receipt Form below and return to SynCardia.
• Quantity in Commerce: 5
• Distribution: US distribution to Virginia and Arizona.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LOZ