China NMPA Product Recall - Pressure pump (Encore26)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a Class II voluntary recall of its Pressure Pump (Encore26) device in China, as announced by the National Medical Products Administration (NMPA) on July 19, 2017. The company's internal report on the issue was dated June 16, 2017. This medical device, registered under NMPA Import Registration No. 20133663453, is used for balloon dilation catheter procedures. The recall addresses multiple customer complaints detailing damage to the aseptic packaging (transparent part) of the product upon opening. An investigation by Boston Scientific Corporation, the manufacturer, identified APET material as the common factor in all compromised packaging, potentially risking product sterility and patient safety. Under the NMPA's regulatory framework, a Class II recall signifies a potential for temporary or medically reversible adverse health consequences. Required actions involve distributing detailed customer communication letters, collecting all affected products, and handling returned devices according to Boston Scientific China’s procedures. Approximately 12,549 units across specified models and batch numbers are implicated in this global recall, with a substantial number distributed in China.