China NMPA Product Recall - Intra-Aortic Occlusion Device

Edwards Lifesciences LLC, the manufacturer, in conjunction with its agent, Edwards (Shanghai) Medical Supplies Co., Ltd., initiated a voluntary Class I recall of specific batches of its Intra-Aortic Occlusion Device. This recall was officially reported on May 23, 2019, to the National Medical Products Administration (NMPA) in response to a critical product issue. The primary concern identified was the potential for the catheter balloon to rupture during use, which could pose a significant risk to patients undergoing cardiopulmonary bypass surgery. The affected products, identifiable by specific model/specification and identification numbers, are registered under National Medical Device Registration Certificate 20183132501. The recall encompassed regions including the United States, Canada, Europe, Latin America, and the Middle East. Despite the global scope of the recall, no sales of the affected batches were made in China, therefore, no further marketing actions or local product retrieval were necessary within that territory.