China NMPA Product Recall - Thoracic aortic stent graft system

Medtronic, Inc., through its Chinese entity Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary recall for specific models of its 24Fr Valiant Thoracic Aortic Covered Stent Graft Systems with Xcelerant Delivery System. The recall, referenced under NMPA Index No. JGXX-2012-10118, was prompted by a significant product defect: users reported the inability to successfully deploy the covered stent. This critical issue affected a limited batch of devices, specifically fewer than 220 units identified by particular serial numbers. The product is intended for treating conditions such as thoracic descending aortic aneurysms and aortic dissections, including in high-risk patients. Under the regulatory oversight of the National Medical Products Administration (NMPA), provincial Food and Drug Administrations were instructed to enhance supervision. Medtronic's required actions involve reporting all corrective measures to the regulatory authorities, notifying affected customers about these actions and ongoing measures, and recalling all unused, affected products from circulation. The company submitted its recall report on October 19, 2012, with the public notification released on November 15, 2012.