China NMPA Product Recall - Endurant II Stent Graft System

Medtronic Inc., through its Medtronic (Shanghai) Management Co., Ltd. entity, initiated a voluntary Class I recall of its Endurant II Stent Graft System. This significant action was publicly reported by the National Medical Products Administration (NMPA) on July 6, 2021. The primary concern prompting the recall is the potential for radiopaque markers to detach from the distal end of the graft covering component during the deployment of the stent graft. This critical issue specifically affects certain models and batches of the Endurant II Stent Graft System (Registration Certificate No.: 20153132422). Operating under the regulatory oversight of the NMPA in China, Medtronic's proactive measure highlights a serious product quality and patient safety concern. The required action by the company is a comprehensive voluntary recall, indicating an urgent need to address the identified product defect. Further specifics regarding the affected product models and batches are detailed in the "Medical Device Recall Event Report Form" attached to the NMPA's announcement.