Z-0659-2017Class I

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

Name: Z-0659-2017 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number...
Creator: SynCardia Systems Inc.
Published: 2016-10-21
License: https://open.fda.gov/license/

SynCardia Systems LLC / initiated 2016-10-21 / Terminated / root cause: manufacturing process

FDA source

SynCardia Systems Inc. began a recall of 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 on 2016-10-21. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0659-2017
Classification: Class I
Status: Terminated
Initiated: 2016-10-21
Posted: 2016-12-08
Terminated: 2017-02-21
Recalling firm: SynCardia Systems LLC
Product: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Product code: LOZ Artificial Heart
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0659-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0659-2017	Class I	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

Product code LOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)