China NMPA Product Recall - Mechanical Heart Valve

The National Medical Products Administration (NMPA) published a notice on November 25, 2021, concerning a voluntary recall initiated by St. Jude Medical for specific Mechanical Heart Valve products. Abbott Medical Products (Shanghai) Co., Ltd. reported this action. The recall, categorized as Class III, addresses identified errors in the labeling and instructions for use associated with particular models and batches of the device (Registration Certificate No.: 20163131281). A Class III recall typically indicates a situation where use of or exposure to a non-compliant product is unlikely to cause adverse health consequences, but the issue requires correction to prevent potential misuse or misunderstanding. St. Jude Medical, the manufacturer, proactively initiated this recall to ensure patient safety and compliance with regulatory standards by rectifying these informational discrepancies. The NMPA's involvement underscores its regulatory framework in overseeing product safety and accurate information dissemination within the medical device sector. Comprehensive information regarding the affected product models, specifications, and batch numbers is detailed in the accompanying "Medical Device Recall Table" and the "Medical Device Recall Event Report Form" attachments.