China NMPA Product Recall - Thrombus Aspiration Control System

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall on March 17, 2017, for its Thrombus Aspiration Control System, Model 5000A, under the guidance of the National Medical Products Administration (NMPA). The recall addresses a critical product defect where the foot switch of the device may become stuck during use, leading to unexpected continuous operation. This malfunction poses a risk of prolonged medical procedures due to necessary troubleshooting and potential procedure cancellation if the issue cannot be resolved and no alternative equipment is available. Of the 95 units manufactured or imported to China, 54 were sold domestically. While the defect presents operational challenges, Boston Scientific has reported no adverse patient events linked to this specific issue. As a required action, the company will issue a comprehensive notification letter to all customers using the affected Thrombectomy Console system. This communication will provide detailed troubleshooting methods and outline the necessary steps users should follow when encountering the foot switch malfunction, aiming to ensure proper device function and patient safety.