China NMPA Product Recall - Abdominal aortic aneurysm stent system

This National Medical Products Administration (NMPA) document, published on July 28, 2017, outlines a voluntary Class III recall initiated by medical device manufacturer Cordis Cashel and reported by its agent, Cordis (Shanghai) Medical Devices Co., Ltd., on July 10, 2017. The recall pertains to specific batches of their Abdominal Aortic Aneurysm Stent System, identified by National Medical Device Registration Certificate 20163460340.

The central issue was the mistaken shipment of five stents, from three distinct batches (models IL1612, IL1308, IL1614), to three hospitals in Italy and Switzerland. These devices were produced at five new manufacturing sites but had not yet obtained the mandatory CE certification, a crucial European regulatory standard confirming compliance with health, safety, and environmental requirements. This constituted a critical lapse in quality control, resulting in the distribution of uncertified medical devices for clinical use outside China; importantly, no affected products were imported into China.

As a corrective measure within this voluntary recall framework, Cordis Cashel will directly engage with the involved hospitals to retrieve the uncertified stent systems. These will then be replaced with compliant products that possess valid CE certification and were manufactured at the company's originally approved production locations. This action aims to uphold patient safety and ensure adherence to international regulatory approvals.