China NMPA Product Recall - LVIS Intraluminal Support Device

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall by MicroVention Europe SARL for its LVIS Intraluminal Support Device (National Medical Device Registration Certificate No. 20213130513), as reported by Beijing MicroVention Medical Technology Co., Ltd. The recall was initiated due to a manufacturing issue where the PTFE (polytetrafluoroethylene) material encasing the stent ring obstructs the stent's proper deployment from the guide tube. This material defect poses a significant risk, prompting the highest level of recall. Further specifics regarding affected product models and secondary levels of recall are detailed in the accompanying 'Medical Device Recall Event Report Form.' This action is consistent with NMPA's regulatory oversight to ensure the safety and efficacy of medical devices within the market.