China NMPA Product Recall - Flow Re-Direction Endoluminal Device (FRED) X System

The National Medical Products Administration (NMPA) of China announced a voluntary Class II recall initiated by MicroVention, Inc. for its Flow Re-Direction Endoluminal Device (FRED) X System. Published on October 21, 2025, this action follows reports from Beijing MicroVention Medical Technology Co., Ltd. detailing manufacturing issues within certain product batches. Complaints and Medical Device Reports (MDRs) indicated defects related to the tantalum wire length and/or attachment methods. These manufacturing flaws pose a risk of abnormal device delivery or opening during surgical procedures, potentially causing significant surgical delays. MicroVention, Inc. is voluntarily recalling the affected FRED X System products, identified under recall number 20253130217. A Class II recall signifies that while the product may cause temporary or reversible adverse health consequences, the probability of serious adverse health consequences is remote. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled devices are available in the associated "Medical Device Recall Event Report Form." This recall demonstrates MicroVention's commitment to patient safety and compliance with NMPA's regulatory standards.