China NMPA Product Recall - Programmable controller

Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., issued a voluntary recall of its programmer controllers, formally reported to the National Medical Products Administration (NMPA) on July 19, 2017. This crucial action stems from a identified safety concern: the potential for external radio frequency interference to disrupt and alter the signals emitted by these programmers. Such interference could inadvertently cause subcutaneous implantable cardioverter defibrillators (ICDs) to execute commands not intended by medical professionals, thereby introducing a risk to patient safety. The affected devices, which are critical for programming and managing implanted cardiac devices, are associated with NMPA Registration Certificate No. 20152212429. In response to this potential malfunction, Boston Scientific Corporation proactively initiated a voluntary recall of the specific programmer controllers. Detailed information concerning the precise recall level, affected product models, technical specifications, and relevant batch numbers is comprehensively documented in the "Medical Device Recall Event Report Form" and an accompanying "Voluntary Recall of Programmable Controllers" attachment. This recall highlights the manufacturer's diligence in addressing potential device anomalies to uphold product integrity and ensure patient well-being under the NMPA's regulatory oversight.