China NMPA Product Recall - Hybrid closed-loop insulin infusion system

The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by Medtronic MiniMed, specifically involving its hybrid closed-loop insulin infusion system (National Medical Device Registration Certificate No. 20233140061). This recall was reported by Medtronic (Shanghai) Management Co., Ltd. on December 28, 2023. The primary reason for this action stems from a critical issue identified in two insulin pumps, bearing serial numbers NG3105252H and NG3401062H, which were distributed in the US market. These devices presented a significant functional problem where patients were unable to upload essential pump data to the accompanying CareLink software. This data upload functionality is crucial for effective patient management and therapy adjustments, making its failure a concern for patient safety and treatment efficacy. A Class II recall indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Medtronic has provided a "Medical Device Recall Event Report Form" for detailed information on affected product models and specifications. This voluntary recall underscores the company's commitment to product safety and compliance with regulatory standards under the NMPA's oversight. The affected devices are subject to retrieval and correction to address the identified software incompatibility issue.