China NMPA Product Recall - Thrombus Aspiration Control System

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Thrombus Aspiration Control System (Thrombectomy Console, Model 5000A) following market feedback. The recall, reported to the National Medical Products Administration (NMPA) on February 8, 2017, addresses a critical issue where the product's foot switch may become stuck, resulting in unexpected continuous operation. This malfunction poses a risk of prolonged medical procedures due to necessary troubleshooting and catheter removal. In severe instances, unresolved issues could lead to procedure cancellation if no alternative equipment is available. While no adverse patient events directly linked to this specific malfunction have been reported to date, the potential for patient impact is significant. As a corrective action, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is responsible for distributing a comprehensive notification letter to all affected customers. This communication will detail specific troubleshooting methods for the foot switch issue and outline the appropriate actions to be taken should the problem arise during use. The recall involves 95 manufactured units, with 54 units sold in China.