Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working

AUDIENCE: Risk Manager, Surgery, Cardiology

ISSUE: FDA notified healthcare professionals of a Class I Recall of the Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t). A specific part of the Freedom Driver drive mechanism may fail and cause the device to stop pumping. Patients do not receive any advanced warning that the device may fail. If it does fail, a red light located in the center of the driver, towards the top, will stay red and a loud continuous alarm will sound.

However, if the Freedom Driver stops pumping, the patient will lose consciousness almost immediately, which means that the warning light and alarm may not be helpful. The patient will likely experience serious injury or death if not immediately switched to a backup driver by a caregiver.

See the FDA Class I Recall Notice for a listing of affected lot/serial numbers.

BACKGROUND: The SynCardia Total Artificial Heath (TAH-t) is a mechanical replacement for a patient’s heart. It is a pump that is implanted into the chest to replace the bottom half of a patient's heart (left and right ventricles). The device is sewn to the remaining top half of the patient's heart (atria). The Freedom Driver System is attached to the TAH-t pump and operates and monitors the device.

RECOMMENDATION: On August 6, 2015, SynCardia Systems sent an Urgent Medical Device Recall letter to their customers. SynCardia told customers they will notify all hospitals that have the affected drivers and replace the drivers with new ones. Additionally, SynCardia informed customers to:

•             Notify any patients with an affected device and exchange the driver

•             A SynCardia representative will assist with replacement and return of the product

•             Return affected Freedom Drivers and complete the Recall Acknowledgement and Receipt Form attached to the letter.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

•             Complete and submit the report Online: www.fda.gov/MedWatch/report

•             Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch Safety Alert, including a link to the Class I Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm463318.htm