Medtronic Updates Faulty HVAD Pump Controller
Medtronic is replacing a faulty controller for its HVAD pump for heart failure, which was linked to a Class 1 product recall.
The updated controller — approved by the FDA on April 7 — addresses several, previously reported potential safety issues, Medtronic says. It strengthens power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins; improves functionality to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and it has redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids, the company says.
The updated controller also includes better internal circuitry designed to improve the device’s reliability.
The company said it has begun to remove current HVAD controllers, with product codes 1400, 1401US and 1407US in select areas.