A class I recall was issued in April, 2015, for all HeartWare Ventricular Assist Systems (VAS) currently in use. The HeartWare VAS helps deliver blood from the heart to the rest of the body. It is commonly used in patients suffering from left ventricular heart failure who are awaiting a heart transplant. Class I recalls are the most serious type of recall issued by the FDA. Class I recalls involve circumstances in which there is a fair probability that use of these products will cause serious injury or death.
The HeartWare VAS consists of a pump implanted in the pericardial space, or space around the heart, and a controller that controls the speed and function of the pump. The recall was due to wearing down of the alignment guide in the power supply connector ports over time. Wear of the alignment guide may lead to connectivity issues and eventually prevent patients from connecting the controller to the VAS. If the implanted pump stops due to these issues it could cause serious injury or death. Thirty three reports of malfunction and one serious injury have been related to this issue so far. 1,763 devices have been recalled in the US.
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