Boston Scientific is initiating a removal of certain batches of the Encore™ 26 Inflation Device and certain batches of Encore™ 26 Advantage kits, NephroMax™ kits and UroMax Ultra™ kits in which the impacted Encore™ 26 inflation devices are a component due to the potential presence of foreign material. The Encore™ 26 inflation device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore™ 26 inflation devices into a balloon dilatation catheter. Recall start date: August 5, 2025
RecallTracker