China NMPA Product Recall - Implantable cardiac resynchronization therapy pacemaker; Implantable cardiac resynchronization therapy pacemaker (Inliven); Implantable cardiac resynchronization therapy pacemaker (trade name: Intua); Implantable Bradycardia Pacemaker; Implantable cardiac pacemaker; Implant; Implantable cardiac pacemaker; Implantable cardiac pacemaker; Implantable cardiac pacemaker; Implantable cardiac pacemaker; Implantable cardiac pacemaker (trade name: Vitalio)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall on June 7, 2021, for several implantable cardiac devices under the oversight of China's National Medical Products Administration (NMPA). The affected products include various models of implantable cardiac resynchronization therapy pacemakers, such as Inliven and Intua, as well as implantable bradycardia pacemakers and other implantable cardiac pacemakers, including the Vitalio trade name. The primary issue prompting this global active safety notice is that these devices may unexpectedly switch to a safety mode. This critical event can occur during programming attempts late in the device's operational life, specifically when the battery's internal impedance becomes unusually high, even before the standard elective battery replacement indicator is reached. This condition poses a significant concern for patient management and device reliability. As a required action, Boston Scientific has decided to voluntarily recall these products. Detailed information regarding specific models, specifications, and affected batches is available in the accompanying "Medical Device Recall Event Report Form." The NMPA, through the Shanghai Municipal Drug Administration, is overseeing this recall to ensure patient safety and compliance with regulatory standards for medical devices.