The FDA has issued a Class I recall for the HeartWare Ventricular Assist System (VAS), citing malfunction in the device's electrical connection that could cause serious patient injury or death.
The FDA has issued a Class I recall for the HeartWare Ventricular Assist System (VAS), citing malfunction in the device’s electrical connection that could cause serious patient injury or death.
The HeartWare VAS is used in patients at risk of death from end-stage left ventricular heart failure who await a heart transplant. However, the alignment guides in the device’s power supply connector ports may wear down over time, which can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to the VAS.
This interruption could cause potentially fatal injury to the patient. In fact, 1 serious injury related to this malfunction has been documented, and the manufacturer has reported 33 incidents of malfunction thus far.
The Class I recall affects more than 1700 HeartWare VAS devices initially distributed in the United States between January 2008 and March 2015. The recalled devices’ product codes are 1101 and 1103, and the serial numbers pertain to all HeartWare systems currently in use.
The manufacturer will replace all defective controllers by the end of June 2016, according to the FDA.
In the meantime, the FDA is advising health care professionals to make appointments with patients using the HeartWare VAS as soon as possible to inspect the device’s power connector ports, and consider replacing the controller, if necessary. Any incidents related to the VAS should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Health care providers with concerns or questions should contact their HeartWare representative or HeartWare’s 24-hour Clinical Support at 1-888-494-6365, or email FSCA@heartware.com.