China NMPA Product Recall - Thrombus Aspiration Control System

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., published on May 8, 2017. The recall pertains to the Thrombus Aspiration Control System (Model 5000A), manufactured by Boston Scientific Corporation, with 54 units sold or imported into China. The core issue identified was that the device's foot switch could become stuck during use, leading to unexpected and continuous operation of the system. This malfunction, though not yet linked to any reported adverse patient events as of the February 8, 2017, report date, presented significant clinical risks. Potential consequences included prolonged microsurgery times due to troubleshooting and catheter removal, and in severe cases, could necessitate surgical cancellation if the problem remained unresolved and no alternative equipment was available. In response, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. committed to issuing a notification letter to all affected customers. This communication would provide essential troubleshooting methods and detail the specific actions required when encountering the foot switch issue, ensuring prompt and safe management of the device.