SynCardia Systems Issues Class I Recall of Freedom Driver System

September 18, 2015 — SynCardia Systems initiated a Class I recall of the Freedom Driver Systems used with the company’s temporary Total Artificial Heart (TAH-t) on Aug. 6, 2015. The recall focused on a specific part of the Freedom Driver drive mechanism that the company said may fail and cause the device to stop pumping.

The SynCardia TAH-t is a mechanical replacement for a patient’s heart, used in patients at risk of imminent death from heart failure who are waiting for a heart transplant. 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.

SynCardia noted that patients do not receive any advance warning that the device may fail. If it does fail, a red light located in the center of the driver, toward 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.

In the Urgent Medical Device Recall Letter, SynCardia told customers they would notify all hospitals that have the affected drivers — in lot numbers 85978 (serial numbers 85978-001 through 85978-040) and 85979 (Serial Numbers 85979-001 through 85979-040) — 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; and
• Return affected Freedom Drivers and complete the Recall Acknowledgement and Receipt Form attached to the letter.

For more information: www.fda.gov/medwatch