China NMPA Product Recall - Single-cut suspension system

Boston Scientific Corporation has initiated a voluntary Class III recall for its single-incision suspension system (Registration Certificate No.: 20163461461). This action was formally reported to the National Medical Products Administration (NMPA) on November 27, 2020, and publicly announced on November 30, 2020. The recall, managed by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., was triggered by a specific product issue that required safety notifications to be issued to customers in South Korea concerning certain models and batches. While the exact nature of the 'problem' is not detailed in the public announcement, the recall level designation as Class III by the NMPA indicates that the use of, or exposure to, the affected product is unlikely to cause serious adverse health consequences. However, it still warrants a corrective action to ensure product integrity and patient safety. The required action for Boston Scientific involves systematically withdrawing the identified problematic single-incision suspension systems from the market. The company has provided a "Medical Device Recall List" and a "Medical Device Recall Event Report Form" containing comprehensive details on the specific affected product models, specifications, and batch numbers to guide this process. This proactive measure demonstrates the company's commitment to compliance with regulatory standards and maintaining trust in medical device quality.