Medtronic Provides Pump-Restart Controller Update for HeartWare Ventricular Assist Device
Medtronic said it will release software embedded in a new controller to any requesting physicians for heart failure patients implanted with the company’s recalled HeartWare ventricular assist device (HVAD) to address delays or failures of the pump to start.
The HVAD, which is no longer being marketed, includes a pump implanted in the space around the heart to pump blood through the heart. The controller directs the speed and function of the pump.
In a letter sent to healthcare professionals, Medtronic explained that it has addressed the delayed-start/failure to start issue using a non-FDA approved algorithm installed in a new controller.
The new controller “is recommended only as a rescue for those patients where the pump does not restart,” the company said.