China NMPA Product Recall - Implantable Bradycardia Pacemakers

On August 20, 2019, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall impacting specific models of implantable bradycardia pacemakers and cardiac resynchronization therapy pacemakers. This recall, reported to the Shanghai Food and Drug Administration and managed under the National Medical Products Administration (NMPA) framework, was prompted by several reports of intermittent oversensing in the affected devices. The core problem identified involves a transient high impedance state that can develop at the electrode leads or their connection points with the pacemaker. This electrical anomaly, when the minute ventilation sensor is activated, has the potential to alter the sensor signal significantly. Such alteration then leads to unintended oversensing within the right atrial or right ventricular channels, which can be observed during intracardiac electrocardiography. In response to these critical performance issues, Boston Scientific is proactively recalling products with Registration Certificate Nos.: 20183120513, 20183120512, and 20183120509. The required action is a voluntary recall designed to address these device malfunctions and uphold product reliability and patient safety standards.