HeartWare International is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System controllers distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012.
The company has written to clinicians and patients to inform them that the affected clinical trial controllers are more susceptible to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or death, according to HeartWare’s news release. HeartWare has improved the design of newer controllers to improve immunity to ESD. The recall does not affect the newer controllers. Ventricular assist devices (VADs) are implanted to assist hearts too weak to pump effectively on their own. HeartWare’s device includes an implantable pump, an external driver, and a power source. It can be used either in or out of a hospital, according to Mass Device. The ventricular assist system is a “bridge to transplant” for heart failure patients.
This recall includes HeartWare controllers (product codes 1400 and 1401XX) with serial numbers CON000001 through CON005472, distributed during the ADVANCE and ENDURANCE clinical trial periods. HeartWare estimates the recall will affect approximately 120 patients in the U.S. HeartWare has advised the FDA of the action.
According to the news release, this recall is an expansion of HeartWare’s voluntary Field Safety Corrective Action, FSCA APR2013. As part of the 2013 action, HeartWare provided information about monitoring controller performance and reducing the potential for an ESD event, which is a known risk for electronic equipment. Patients can reduce the risk of ESD, the company says, by avoiding dry environments, certain fabrics and materials such as silk clothing and carpeting, electronic devices prone to static electricity and activities such as vacuuming. Since the 2013 notice, HeartWare has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to a pump stop.