China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Boston Scientific International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class I recall for its Subcutaneous Implantable Cardiac Defibrillator (Registration No.: 20153212410). The recall, publicly announced on July 14, 2017, was prompted by a critical device malfunction. It was identified that a memory anomaly within the affected units led to atypical repeated power output, posing a potentially serious health risk to patients. This issue necessitated the highest level of recall, classified as Class I by regulatory standards. Under the oversight of the National Medical Products Administration (NMPA) of China, the company undertook this corrective action to address the device's deficiency. Specific details regarding the models, specifications, and batch numbers of the impacted products are documented in the "Medical Device Recall Event Report Form," which serves as an attachment to the official recall notice. Boston Scientific's proactive measure aims to mitigate potential patient harm stemming from the identified malfunction and ensure the safety and efficacy of its medical devices in the market.