China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., initiated a voluntary global Class I recall for its Subcutaneous Implantable Cardioverter Defibrillator (SID), model 1010 (National Medical Device Registration Certificate No. 20153212410). This action, reported to the National Medical Products Administration (NMPA) on July 4, 2017, followed a critical incident in May 2017 where a patient in the United States died. An investigation confirmed a memory malfunction within the SID that caused atypical and repeated power outputs, directly contributing to the patient’s death. The recall affects specific batches, with 54 units identified in China. As a Class I recall, it signifies a serious health risk. Boston Scientific's required actions include issuing customer communication letters to inform affected parties. Crucially, the company is developing a software update to rectify the memory malfunction and will arrange for these updates to be applied to all affected SIDs currently on the market, rather than requiring the physical return of devices.