China NMPA Product Recall - Implantable Bradycardia Pacer

The National Medical Products Administration (NMPA) announced on October 8, 2024, that Cardiac Pacemakers, Incorporated, a wholly owned subsidiary of Boston Scientific Corporation, is voluntarily recalling certain implantable Bradycardia pacemakers. This action was initiated due to the discovery of duplicate serial numbers within a specific batch of these devices, identified as Pacer 1 models (National Medical Device Registration Certificates 20183120509, 20183120512, and 20183120513). The recall, reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., is classified as a Level III event, indicating a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. It is important to note that the affected products were not imported into the People's Republic of China. This voluntary recall demonstrates the company's commitment to product safety and compliance with regulatory standards, ensuring the integrity of medical devices distributed globally, even if the specific batch was not distributed in a particular region.