The mobile power units of certain HeartMate 3 and HeartMate II LVADs have been experiencing “sudden, unexpected performance issues” such as turning on, off or even restarting with no warning. These issues can potentially be fatal, according to an alert shared by the FDA.

The devices are being recalled and discontinued after the FDA shared a series of concerns. This is a Class I recall, meaning using this system could result in serious injuries or death.

The world is in the throes of an AFib pandemic, one that could potentially get worse in the years ahead due to population growth, economic hardships and rigid resource limitations. According to the Heart Rhythm Society, one way to effectively combat this issue is the development of more AFib Centers of Excellence.