China NMPA Product Recall - Insulin infusion pump

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class I recall of its insulin infusion pumps (Registration Certificate No.: 20173141951) following the discovery of a significant security vulnerability. Published on November 19, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, the recall addresses a potential flaw in the MMT-503EU remote control. The issue involves a security vulnerability where a malicious individual could potentially copy and replay radio frequency signals from a user's remote control. This could lead to the involuntary administration of high-dose insulin or the unauthorized pausing or resuming of the pump's infusion for the originally targeted device. Exploiting this vulnerability requires specialized technical skills and equipment. As of October 2021, Medtronic reported no actual attacks or related cybersecurity incidents. The company is taking proactive measures by recalling the affected remote controls and insulin infusion pumps to ensure patient safety and device integrity. Detailed information about specific models, specifications, and batches is available in the