China NMPA Product Recall - Pipeline Flex Embolization Device with Shield Technology

Micro Therapeutics, Inc. DBA ev3 Neurovascular initiated a voluntary recall of its Pipeline Flex Embolization Device with Shield Technology. This recall, published by the National Medical Products Administration (NMPA) on June 4, 2025, stems from an critical issue: incorrect product size information displayed on the packaging labels. Such errors are significant as they could potentially lead to the use of an inappropriately sized device, posing risks to patient safety. The device holds National Medical Device Registration Certificate No. 20233130078 under the NMPA's regulatory framework. Notably, the products implicated in this specific recall event were not imported into China, mitigating direct impact on the Chinese market. Although a specific recall level was not detailed in the report, the company, in cooperation with Coca-Cola Medical Devices International Trading (Shanghai) Co., Ltd., is undertaking the necessary actions to address the packaging discrepancy. Detailed information concerning the affected models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form," ensuring comprehensive traceability and management of the issue.