Boston Scientific Safety Notice on Ablation System

Boston Scientific has issued an urgent field safety notice about installing a firmware update for its Maestro 4000 Cardiac Ablation System. The update addresses the potential for “unintended continuation of radiofrequency (RF) energy delivery from the Maestro 4000 Cardiac Ablation System after releasing the foot switch,” the notice says. Only devices using the optional foot switch accessory are affected by the unintended RF delivery, the company says. “Unintended RF energy delivery can be detected if, after releasing the foot switch, RF parameters continue displaying on the control panel and the system continues emitting an audible tone,” it says.

The firmware update has recently been approved and Boston Scientific says it is beginning to upgrade affected devices. It notes that the update will eliminate one potential cause of the unintended RF delivery. If unintended RF delivery is detected, users are instructed to manually power off the device.