China NMPA Product Recall - Intra-aortic occlusion catheter

On November 6, 2018, the National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Edwards Lifesciences LLC, the manufacturer of an intra-aortic occlusion catheter (CFDA (Imported) No. 3774579). The recall was primarily due to an error in the product's instruction manual, which incorrectly listed accessories, specifically a buckle and sewing ring, that had already been removed from the device. Edwards (Shanghai) Medical Supplies Co., Ltd. served as the agent for this global recall. While the recall was a worldwide action, the regulatory report explicitly states that no affected products were sold or imported into China, meaning the sales quantity in China was zero. Therefore, despite the recall notification under the NMPA framework, no specific corrective actions or handling methods were required within the Chinese market. The intra-aortic occlusion catheter is indicated for patients undergoing cardiopulmonary bypass surgery, assisting with aortic occlusion, drainage, and the delivery of cardiac sedation fluid.