China NMPA Product Recall - Implantable cardiac resynchronization therapy pacemaker, implantable cardiac pacemaker

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for specific implantable cardiac resynchronization therapy pacemakers and implantable cardiac pacemakers. The manufacturer, Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation, identified accelerated battery depletion caused by hydrogen induction in approximately 2,900 devices, which increases the risk of premature device replacement. The affected models include U128, U228, L200, L221, L300, L301, L321, L100, L101, and L121. This action was reported to China's National Medical Products Administration (NMPA) on September 14, 2018, and published on October 30, 2018.

Required actions include recommending routine patient follow-up procedures, such as monitoring via the LATITUDE™ NXT remote patient management system, at intervals no longer than six months to identify device behavior. To date, no injuries have been reported related to this issue. Boston Scientific clarified that this field action primarily affects products outside of China. Therefore, while reported to the NMPA, the company stated no further domestic recall measures, investigation reports, or recall plans would be submitted within China beyond the initial notification.