China NMPA Product Recall - Echelon™ Micro Catheter

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Micro Therapeutics Inc. dba ev3 Neurovascular, the manufacturer of the Echelon™ Micro Catheter. This recall was reported to the NMPA by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. and published on November 14, 2022. The primary issue prompting the recall was the discovery of liquid-soaked outer packaging for specific models and batches of the product during its transportation to Brazil. While no inspection dates were provided, the action is a manufacturer-initiated voluntary recall under the oversight of the NMPA, China's medical product regulatory authority. Affected product models, specifications, and batch details are documented in the "Recall Event Report Form." The company is required to manage and communicate this recall to address the identified product packaging integrity concern.