Boston Scientific (NYSE:BSX) issued an urgent field safety notice to warn of a firmware installation update for its Maestro 4000 cardiac ablation system after issues with radiofrequency delivery.
In June 2018, Boston Scientific notified customers of the potential for the unintended continuation of radiofrequency energy emitted from the device after releasing its foot switch. After releasing the foot switch, unintended radiofrequency energy delivery can be detected if the parameters continue displaying on the control panel and the system continues emitting an audible tone.
According to the safety notice, only systems using the optional foot switch accessory are susceptible to the radiofrequency issue. Instructions in the device’s manual tell users to press the radiofrequency power control button on the system’s controller or remote control.
Boston Scientific’s latest update on the device shared that a firmware update to resolve the radiofrequency issue has been approved and the company is beginning the process of updating the firmware of the Maestro 4000 systems. The company did warn that the update eliminates one potential cause of the behavior, but risks for other potential causes of unintended radiofrequency delivery may remain.
Users are urged to allow Boston Scientific representatives access to their Maestro 4000 systems within their facilities when a firmware upgrade is scheduled. If the radiofrequency issue continues, users are instructed to follow the guidelines in the manual and report the occurrence and clinical outcome promptly to their local Boston Scientific representative.
