The FDA notified the public of a Class I recall of SynCardia Systems' Total Artificial Heart, saying a specific part of the device known as the Freedom Driver that operates and monitors the heart could fail.
Device failure is accompanied by a loud continuous alarm, but "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," the FDA warns.
The now-completed recall covered 56 drivers in the U.S., Turkey and France, as well as 21 that that were in use on patients, according to the FDA's recall database. In the U.S., 29 Freedom Drivers were recalled from 11 centers that care for 12 patients on the device.
On August 6, SynCardia sent customers a letter, telling customers they will replace the affected drivers, and about a week later all potentially affected units were replaced, according to a company release.
"The patient in the incident that prompted the recall briefly lost consciousness when his primary unit alarmed and stopped pumping, but quickly regained consciousness when his caregiver switched the patient to his backup Freedom driver. He received his replacement Freedom drivers and is doing well with no permanent injury," said SynCardia CEO Michael Garippa, in a statement. "No other incidents were reported."
The SynCardia temporary Total Artificial Heart is designed to replace a failed human heart in patients with advanced heart failure. It is the only total artificial heart available in the U.S., EU and Canada as a bridge to heart transplantation. Left ventricular assist devices are also used a bridge to transplantation, but the Total Artificial Heart is for even more severe cases, or those patients at imminent risk of death from irreversible biventricular failure. The device replaces the functionality of both right and left ventricles, as well as all four heart valves.
"The malfunction was caused by an unauthorized rework of a component by a supplier," Garippa said in a statement. "The supplier worked quickly with us to identify and resolve the problem."
The safety scare comes as SynCardia prepares to offer 2.5 million shares via an IPO, and is currently conducting a "roadshow" to build up excitement for its offering. But the recall isn't the only recent incident.
It comes on the heels of an FDA warning about the Total Artificial Heart Companion 2 Driver System. Post-market data showed that 12 (or 60%) of Total Artificial Heart patients who received a pre-implant intervention (such as intra-aortic balloon pump or extracorporeal membrane oxygenation) died within three months of implantation, compared to 3 (or 17%) such patients who used the previous generation device, the Circulatory Support System Console, which was approved in 2004.
Besides the safety implications, the letter was significant because it showed that they agency is inspecting post-market data. Use of post-market data is an important plank in the FDA's strategy of approving devices faster based on less premarket data, and it has at times been accused of skimping on post-market data collection and analysis.
Editor's Note: This article has been updated with a release from the company.