China NMPA Product Recall - Insulin Pump

On November 18, 2021, Medtronic (Shanghai) Management Co., Ltd., on behalf of Medtronic MiniMed, initiated a voluntary Class I recall for its MiniMed Insulin Pumps. The recall addresses a potential security vulnerability identified in the remote control feature of the MMT-503EU model. This issue carries a significant risk, prompting the National Medical Products Administration (NMPA) to classify it as a Class I recall, which signifies a high probability of serious adverse health consequences or death. The recall specifically targets certain models, specifications, and batches of the insulin pump, as detailed in the "Medical Device Recall Event Report Form" and the "Global List of Affected Products". Medtronic is proactively taking steps to mitigate the risk associated with this vulnerability by recalling the affected devices. This action ensures patient safety and compliance with regulatory standards set by the NMPA. Users of Medtronic MiniMed Insulin Pumps, particularly the MMT-503EU model, are advised to consult the provided documents for specific product identification and further guidance.