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

FDA Device Recall #Z-0659-2017 — Class I — October 21, 2016

Recall Summary

Recall Number Z-0659-2017
Classification Class I — Serious risk
Date Initiated October 21, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SynCardia Systems Inc.
Location Tucson, AZ
Product Type Devices
Quantity 5

Product Description

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

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.

Distribution Pattern

US distribution to Virginia and Arizona.

Lot / 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

Other Recalls from SynCardia Systems Inc.

Recall # Classification Product Date
Z-2731-2015 Class I Temporary Total Artificial Heart (TAH-t) with F... Aug 6, 2015
Z-0620-2013 Class II Companion External Battery, Part Number: 293001... Dec 5, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.