China NMPA Product Recall - Abdominal aortic aneurysm stent system

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Cordis Cashel, with Cordis (Shanghai) Medical Devices Co., Ltd. serving as the agent. The recall, published on July 28, 2017, pertains to the Abdominal Aortic Aneurysm Stent System (Registration Certificate No.: 20163460340). The core issue stemmed from the erroneous shipment of five stents, comprising three batches (models IL1612, IL1308, IL1614), to three hospitals in Italy and Switzerland. These specific products were manufactured at five new production sites and had not yet acquired the required new CE certification for distribution in those regions. Significantly, none of the affected products were imported into China. Under the NMPA's regulatory framework for medical device recalls, Cordis Cashel is implementing corrective actions. The manufacturer's plan involves directly contacting the identified hospitals to arrange the return of the uncertified devices. These will then be replaced with properly CE-certified products manufactured at the original, approved production facility, ensuring adherence to international market requirements. This incident underscores the critical importance of robust product certification processes for new manufacturing locations.