China NMPA Product Recall - Intra-aortic occlusion catheter

Edwards (Shanghai) Medical Supplies Co., Ltd. has initiated a voluntary Class II recall of its intra-aortic occlusion catheter, as reported on January 22, 2019. This action was taken due to a critical design flaw identified in the product: leakage of cardiac arrest fluid between the perfusion chamber and pressure chamber of the aortic root. This defect compromises the catheter's ability to continuously deliver cardiac arrest fluid to the heart, posing a significant risk to patient safety. The recall, detailed under Shanghai Food and Drug Administration Medical Device Registration Certificate No.: 2019-003 and product Registration Certificate No.: 20183132601, is overseen by the National Medical Products Administration (NMPA). The company is providing a "Medical Device Recall Event Report Form" with specific information on affected models, specifications, and batch numbers. The recall highlights the importance of medical device vigilance and the regulatory framework's role in ensuring product safety within China.