The HeartWare HVAD System is currently approved as a bridge to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery and as destination therapy in patients for whom a heart transplant is not planned. Compared with other commercially available durable left ventricular assist devices, the Medtronic HVAD System has demonstrated a higher frequency of neurological adverse events and mortality, according to a growing body of observational clinical comparisons. Medtronic has also received over 100 complaints involving a delay or failure to restart of the HVAD pump. These reports included 14 deaths and 13 cases where an explant was required. Consequently, Medtronic has decided to stop the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter to health care providers to immediately stop new implants of the device.