China NMPA Product Recall - Dry aortic valve EDWARDS INSPIRIS RESILIA Aortic Valve

The National Medical Products Administration (NMPA) issued an announcement on May 8, 2024, regarding a voluntary Class III recall initiated by Edwards Lifesciences LLC, supported by Edwards (Shanghai) Medical Supplies Co., Ltd. This recall pertains to the EDWARDS INSPIRIS RESILIA Aortic Valve, registered under National Medical Device Registration Certificate No. 20203130521. The primary issue identified was potential inconsistencies between the size information and serial number displayed on the outer packaging label and those present on the sterile packaging of the device. Edwards Lifesciences LLC, as the manufacturer, is undertaking this action to address the labeling discrepancy. A Class III recall signifies that the probability of the product defect causing adverse health consequences is low, but corrective action is necessary to maintain product quality and regulatory adherence. The regulatory framework governing this action is the NMPA's comprehensive medical device oversight. The company's required action involves a voluntary recall of all affected product batches to rectify the identified labeling errors, ensuring accurate and consistent product information for users. Further specifics on the impacted products and batches are detailed in the Medical Device Recall Event Report Form.