Medtronic Modifies Software for HeartWare Pump Problem

Medtronic has announced that a backup controller with modified software can be used if the primary controller fails to restart its HeartWare Ventricular Assist Device system. An agency notice says that the company 6/2021 stopped selling and distributing the device based on an increased risk of mortality and neurological adverse events in patients using the device, and a malfunction where the device may fail to restart. Both problems may lead to serious injuries or death, it said.

A recent letter from Medtronic says two groups of the pumps may experience a delay to restart or failure to restart at a higher rate than other device groups. “Those two distinct subgroups were from specific component manufacturing lots that have exhibited differing failure rates,” it says. To address this, the company says it has developed an alternate pump start algorithm within the controller software that may help restart pumps for patients.