China NMPA Product Recall - Insulin Pump

The National Medical Products Administration (NMPA) of China announced a Class I voluntary recall initiated by Medtronic (Shanghai) Management Co., Ltd. for its Medtronic MiniMed Insulin Pump, model MMT-503EU. This recall, reported on December 10, 2021, addresses a potential security vulnerability identified in the remote control of the affected devices. As the manufacturer, Medtronic MiniMed (Registration Certificate No.: 20173141951) proactively initiated this action. The Class I designation indicates that the use of these medical devices could lead to serious adverse health consequences or death, highlighting the critical nature of the security flaw. The NMPA serves as the primary regulatory body overseeing this recall. While specific inspection dates are not detailed in this recall announcement, the company's required action involves a comprehensive voluntary recall of the implicated products. Further detailed information regarding specific models, specifications, and batches has been provided in a dedicated 'Medical Device Recall Event Report Form' to ensure all necessary steps are taken to mitigate patient risk.