China NMPA Product Recall - Abdominal aortic aneurysm stent system

The National Medical Products Administration (NMPA) announced a Class III voluntary recall of Cordis Cashel's Abdominal Aortic Aneurysm Stent System on July 28, 2017. Initiated by the manufacturer, Cordis Cashel, through its agent, Cordis (Shanghai) Medical Devices Co., Ltd., the recall addressed a critical regulatory lapse. The core issue stemmed from the erroneous shipment of five stent units, produced at newly established manufacturing sites, to three hospitals located in Italy and Switzerland. A significant violation was that these new production facilities had not yet acquired the mandatory new CE certification, which is essential for the legal distribution of medical devices within European markets. Importantly, none of the affected products, which included models IL1612, IL1308, and IL1614, were imported into China. As a corrective action, Cordis Cashel is proactively engaging with the identified hospitals to retrieve the uncertified devices. The company will replace these with compliant products manufactured at its original, fully CE-certified production facility, ensuring adherence to regulatory standards and patient safety.