China NMPA Product Recall - Abdominal aortic endovascular stent graft system

Gore Industrial Products Trading (Shanghai) Co., Ltd., in collaboration with manufacturer Gore and Tongren Co., Ltd., initiated a voluntary Class II recall of its Abdominal Aortic Vein-Covered Stent System. This action, reported on December 19, 2019, through the Shanghai Municipal Drug Administration Website, was prompted by a significant change in the product's instructions for use. The National Medical Products Administration (NMPA) oversees this regulatory framework. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is required to implement the recall according to the attached "Medical Device Recall Event Report Form" to address the discrepancy in product information and ensure patient safety. This measure underscores the company's commitment to compliance with regulatory standards and safeguarding public health.