Nearly seven years’ worth of pacemakers manufactured by Boston Scientific have been recalled over concerns that they can fail to a backup mode and no longer properly pace the patient’s heart. The recall affects 48,000 Ingenio pacemakers manufactured between September 2011 and December 2018. The units continued to be distributed to medical providers through August 1, 2020.
According to the Boston Business Journal, safety mode was created as a failsafe in case the units’ batteries were no longer functioning as designed. Rather than completely resetting, the pacemaker was designed to fail to a safety mode that would continue pacing the patient’s heart until a replacement could be installed. Ingenio pacemakers that have gone into safety mode cannot be reset or reprogrammed and the only option is the installation of a replacement pacemaker.
The tens of thousands of Ingenio pacemakers that have been recalled appear to be at risk of failing to safety mode even though a transition to such a mode is not necessary. Thus far, 65 reports of safety mode failovers have been reported. And, while no fatalities have occurred, the risks are too great when the device in question is integral to keeping a cardiac patient’s heart working properly. Three injuries have been reported.
The recall should be easily absorbed by Boston Scientific’s showing of “stronger business results” than were expected in the face of the COVID-19 pandemic. In fact, the corporation had such a good showing that CEO Mike Mahoney was able to take home $13.8 million dollars last year, even after forgoing 99% of his base salary for six months. The amount equates to 232 times the median amount paid to a Boston Scientific employee.
Not a bad take when you’ve been pumping out faulty pacemakers for almost seven years.
