China NMPA Product Recall - Implantable cardiac pacemaker; Implantable cardiac resynchronization therapy pacemaker

Boston Scientific International Medical Trading (Shanghai) Co., Ltd., in conjunction with Boco International Medical Trade (Shanghai) Co., Ltd., has issued a voluntary Class II recall for implantable pacemakers, specifically Implantable Bradycardia Pacemakers, Implantable Cardiac Pacemakers, and Implantable Cardiac Resynchronization Therapy Pacemakers. This action, dated June 7, 2021, and overseen by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, is an update to a prior recall reported on September 14, 2018. The recall expansion is prompted by notification from the company's headquarters, indicating that additional products with specific serial numbers worldwide may share similar issues not covered by the initial action. Consequently, Boston Scientific is broadening the scope of the original recall to include these newly identified devices. Comprehensive details regarding the affected models, specifications, and batches are provided in the accompanying "Medical Device Recall Event Report Form."