China NMPA Product Recall - Pressure pump (Encore 26)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd., a subsidiary of Boston Scientific Corporation, initiated a voluntary Class II recall of its Encore26 Pressure Pump. The recall was publicly reported by the National Medical Products Administration (NMPA) on August 8, 2017, following Boston Scientific's internal report on June 16, 2017. The primary issue identified was damage to the aseptic packaging (transparent part) of the Encore26 Pressure Pump, specifically involving packaging made from APET material. Users reported finding the aseptic packaging compromised upon opening the outer box, raising significant concerns about product sterility and potential patient safety risks.

Operating under the regulatory oversight of the NMPA, with the product holding CFDA (Imported) No. 20133663453 registration, Boston Scientific has outlined specific corrective actions. These include sending detailed customer communication letters to affected clients, explaining the recall's rationale and necessary steps for customers. Furthermore, the company is actively retrieving all impacted products from customers and will manage the returned items according to its established internal protocols. This recall affects approximately 12,098 units in China across various identified lot numbers, ensuring the removal of potentially compromised devices from the market.