China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Boston Scientific Corporation initiated a Class I global voluntary recall for its Subcutaneous Implantable Cardioverter Defibrillator (S-ICD, model 1010). This action, overseen by China's National Medical Products Administration (NMPA), was formally reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. on June 30, 2017, and published by the NMPA on July 10, 2017. The urgent recall was prompted by a severe memory malfunction within the device, which caused atypical and repeated electrical outputs. This critical defect directly resulted in the death of a patient in the United States in May 2017. A total of 54 units were identified as affected globally, with 34 units (Model A209) distributed in China. Boston Scientific's required actions include providing comprehensive customer communications to explain the recall's specifics and the necessary steps. Furthermore, the company is developing a crucial software update to correct the malfunction and will arrange for this update to be applied to all affected S-ICD devices currently on the market as soon as it becomes available.