China NMPA Product Recall - Implantable cardiac pacemaker

The National Medical Products Administration (NMPA) announced a Class II voluntary recall on March 26, 2021, initiated by St. Jude Medical Cardiac Rhythm Management Division. The recall specifically targets certain models and batches of implantable cardiac pacemakers due to identified electrical faults. Abbott Medical Products (Shanghai) Co., Ltd. reported the issue, prompting the manufacturer's decision to withdraw the affected devices from circulation. The recalled products are registered under certificate numbers 20153120178, 20153121881, and 20183120455. The primary concern necessitating this action is the presence of electrical malfunctions within these critical medical devices, which could pose risks to patient safety. The NMPA's regulatory framework ensures that medical devices adhere to stringent safety and quality standards within its jurisdiction. The required action involves a comprehensive voluntary recall by St. Jude Medical to address these electrical defects and mitigate any potential adverse events. Detailed information regarding the specific models, specifications, and batch numbers is provided in the "Medical Device Recall Event Report Form" attachment. This proactive measure underscores both the manufacturer's accountability and the NMPA's dedication to safeguarding public health.