The FDA has labeled the recalled HeartWare Ventricular Assist Device (HVAD) a Class 1 recall, the most serious recall classification, after the potential risk for serious injury or death. Last month there were two issues that caused the Heartware Device recall. One of the issues was related to electrical problems while the other was due to a loose connector. Both of these issues can contribute to the system to stop functioning.
The HVAD System includes a ventricular assist device (VAD), or mechanical pump, that pumps blood to the body when one of the heart’s natural pumps (a ventricle) does not perform well. The controller is a small computer that monitors the pump. These implanted systems can allow people with advanced heart failure to return to a fuller life while they await heart transplantation. The device was developed for patients to assist the blood to flow from their heart to the rest of their body. The recalls last month both involve problems caused by moisture entering the device. If the system gets moisture in it, there could be an electrical malfunction that would lead to the pump to stop working. A connection failure can also potentially cause the pump to stop working. The FDA warns that electrical malfunctions or stopping the pump may lead to serious adverse health consequences, including death of the user.
HeartWare has a long history of recalls for faulty devices. Last year, another Class 1 Recall was put on the Ventricular Assist Systems due to a malfunction caused by bent pins in a faulty power supply connector port. In August of 2015, a recall was issued for the HeartWave device after reports of bleeds, blood clot complications, strokes and other injuries. In 2014, HeartWare VADs were affected by another recall after two deaths and four serious injuries.
The most recent HeartWare device recall is an extremely serious situation. If you or someone you know has been injured from using this system, we want to help you. Contact our office today to discuss your case. We know that this may be a very difficult time for you.