Medtronic abruptly pulled its HeartWare Heart Ventricular Assist Device pump system from the market June 3 after a series of Class I recalls in 2021 and reports of patient injuries and deaths associated with device malfunctions.
In a notice following Medtronic's announcement, the FDA said that the company has "received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary."
The HeartWare HVAD system has a history of problems, with the FDA publishing 13 Class I recall notices since 2013. Reasons for recalls range from electrostatic discharges causing pump failures in 2015, to unintended electrical disconnections between the power source and the controller of the pump in 2018, to the recall of numerous battery, data and adapter cables in April.
The decision to discontinue the system comes just five years after Medtronic bought HeartWare International, bringing questions about the billion-dollar acquisition now that the flagship product from the deal is no longer available.
Medtronic is coordinating with Abbott Laboratories to ensure patients requiring the system have available comparable devices.
Below is a compendium of MedTech Dive's coverage of HeartWare HVAD pump issues, FDA recalls and Medtronic's decision to discontinue the system.