China NMPA Product Recall - Thrombectomy Console (Thrombus Aspiration Control System)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall on April 6, 2017, for its Thrombus Aspiration Control System, model 5000A. This action was prompted by market feedback indicating that the device's foot switch could become stuck during use, leading to unexpected continuous operation. This malfunction poses a risk of prolonged procedure times, necessitates troubleshooting, and in severe cases, could lead to procedure cancellation if unresolved. While 95 units were manufactured and 54 sold in China, no adverse patient events related to this issue have been reported to date. Operating under the oversight of the National Medical Products Administration (NMPA), Boston Scientific is taking corrective action by issuing a notification letter to all affected customers. This letter will provide detailed troubleshooting methods for the foot switch issue and outline the specific actions users should take when encountering the problem to ensure patient safety and operational efficiency.