Medtronic Heartware Ventricular Assist Device System — recall 62553

Reported risk: On June 3, 2021, the Medtronic HVAD TM System was recalled due to an increase in neurological adverse events and mortality, as well as a potential for the internal pump of the Medtronic HVAD TM System to delay or fail to restart. Medtronic is now communicating additional instructions as a follow-up to a Recall Notice posted on June 9, 2021. Medtronic HeartWare Ventricular Assist Device (HVAD™) System, model 1104, more than 10 lot numbers, contact the manufacturer (see details below) for additional information. The HVAD TM System is a Left Ventricular Assist Device (LVAD) that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure. The HVAD TM System was authorized to be used as a bridge to cardiac transplantation in eligible patients. The Medtronic HVAD TM System was recalled on June 3, 2021, due to a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events and mortality with the system when compared to other commercially available durable LVADs. Considering these findings and given the availability of alternative devices, Medtronic has decided to stop the distribution and sale of the HVAD TM System. In addition, in December 2020, Medtronic issued an Urgent Medical Device Communication informing physicians of an issue where the internal pump of the HVAD TM System may experience a delay or fail to restart. The communication explained that a subset of HVAD TM System included an internal pump component from three specific lots that increased the risk of restart failure. Between January 2009 and April 22, 2021, Medtronic received a total of 106 complaints globally involving a delay or failure to restart the internal pump of the HVAD TM System, including 14 patient deaths and 13 cases where an explant was necessary. Aside from the three specific lots that were recalled in December 2020, Medtronic has not been able to determine the root cause for other restarting failures.