China NMPA Product Recall - Abdominal aortic aneurysm stent system

On July 31, 2017, the National Medical Products Administration (NMPA) publicized a voluntary Level III recall by Cordis Cashel, the manufacturer of an Abdominal Aortic Aneurysm Stent System. This recall, reported by their agent Cordis (Shanghai) Medical Devices Co., Ltd., stemmed from a significant regulatory compliance issue. The manufacturer had mistakenly distributed five stent systems, produced at five newly established manufacturing sites, to three hospitals in Italy and Switzerland. Crucially, these new production locations had not yet secured the required CE certification, a mandatory regulatory approval for medical devices marketed within the European Economic Area. The affected products, specifically models L1612, IL1308, and IL1614, were identified by unique batch numbers, and no units were imported into China. The core violation was the shipment of devices lacking proper market authorization due to a change in manufacturing location. To address this, Cordis Cashel committed to contacting the identified hospitals, CMTEC SRL, 3P Medical X, and Inselspital Bern, to retrieve all non-CE certified products. These would then be replaced with equivalent, fully CE-certified stent systems produced at their originally approved manufacturing facilities, thereby ensuring adherence to international medical device standards and safeguarding patient safety.