China NMPA Product Recall - Thrombus Aspiration Control System

Boston Scientific International Medical Trading (Shanghai) Co., Ltd., on behalf of Boston Scientific Corporation, initiated a voluntary Level III recall of its Thrombectomy Console (Model 5000A) following market feedback. The recall, reported on February 8, 2017, and published by the National Medical Products Administration (NMPA) on March 17, 2017, addresses a critical product defect. The main issue involves the device's foot switch, which may become stuck during use, resulting in unintended continuous operation of the aspiration system.

This malfunction can lead to significant procedural disruptions, including prolonged procedure times due to necessary troubleshooting and catheter removal actions. In severe instances, if the problem persists and no alternative device is available, the procedure may need to be canceled. Fortunately, Boston Scientific confirmed that as of the report date, no adverse patient events directly related to this specific malfunction had been reported.

To rectify the situation, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is implementing corrective actions. They will issue a formal notification letter to all affected customers. This communication will detail troubleshooting methods to address the stuck foot switch issue and outline the required actions customers should take if they encounter the problem. The recall affects 95 units manufactured globally, with 54 units distributed within China.