Heartware Ventricular Assist System Recall Issued Due to Injury, Death Risk

Federal health regulators indicate that a recall has been issued for the HeartWare Ventricular Assist System, due to a risk that it may fail and pose a risk of death for patients.  

This week the FDA warned that a HeartWare Ventricular Assist System recall issued in December should be considered a class 1 medical device recall, which is the most serious category. The classification came after the manufacturer indicated that the device may stop working when a patient needs it.

The HeartWare, also known as a ventricular assist device (VAD), is used as a bridge device on patients suffering from advanced heart failure while they await cardiac transplantation . It is used during emergency medical flights on airplanes and helicopters, as well as in hospitals, to keep patients alive until a heart transplant can be performed.

According to the reports received by HeartWare, Inc., the driveline connector locking mechanism on the device may fail to engage on some units. As a result of this manufacturing defect, the device may fail and stop pumping, leading to serious injury or death of the patient.

The recall affects the HeartWare Ventricular Assist System with Catalog Numbers 1100, 1101, 1102, 1103, 1104, and 1205. Serial numbers of devices affected by the recall include HW001 to HW 11270 and HW20001 to HW 20296. The recalled devices were manufactured between March 6, 2006 and October 17, 2013. They were distributed between March 17, 2006, and November 29, 2013.

The company first warned customers on December 12, 2013, with an Urgent Medical Device Correction letter. However, now the FDA has determined it is a class 1 medical device recall, suggesting that continued use of the Heartware system poses a risk of serious adverse health outcomes or death. HeartWare has indicated that it will soon send out an updated letter to customers, alerting them to the recall status.

The FDA advises patients that if the driveline becomes disconnected from the patient controller, a “VAD Stopped” high priority alarm will sound, They should immediately reconnect the driveline to the controller as instructed by the patient manual and contact their doctor or VAD coordinator.

Doctors are advised to follow up visit with patients with the affected HVAD to inspect the driveline connector. They are also advised to inspect the connector for proper locking and to ensure that the assembly remains secure every time the device is implanted and at every routine visit.