China NMPA Product Recall - Programmable controller

The National Medical Products Administration (NMPA) publicized a voluntary recall initiated by Boston Scientific Corporation, specifically concerning its programmer controllers. Announced on July 12, 2017, and reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., this action addresses a significant safety issue identified with these medical devices. The core problem involves potential radio frequency (RF) interference, which may disrupt and alter the radio signals transmitted by the programmers during the programming of subcutaneous implantable cardioverter defibrillators (ICDs). This disruption could inadvertently cause the implanted ICDs to execute unexpected or incorrect commands, potentially compromising device functionality and patient safety. The recall, detailed under Registration Certificate No.: 20152212429, covers specific affected product models, specifications, and batches, which are comprehensively listed in the "Medical Device Recall Event Report Form" attachment. Boston Scientific Corporation is executing this voluntary recall as the primary corrective action required to mitigate the identified risks. This regulatory oversight by the NMPA ensures adherence to medical device safety standards and the implementation of essential measures to safeguard public health.