China NMPA Product Recall - Thoracic aortic endovascular stent graft system

Gore Industrial Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its thoracic aortic vessel covered stent system (Registration No.: 20153463498), as announced by the National Medical Products Administration (NMPA) on November 13, 2017. This critical action was prompted by adverse event reports originating from overseas markets, detailing instances of incomplete and/or partial stent release. These product performance issues represent a significant concern regarding patient safety and the device's intended efficacy. The recall demonstrates the company's proactive approach to addressing serious product malfunctions. The NMPA's oversight ensures compliance with medical device regulations. While specific inspection dates are not detailed in this document, the recall notification itself signifies a regulatory compliance action triggered by identified product defects. The primary required action involves the systematic retrieval of all affected batches of the thoracic aortic vessel covered stent system. Detailed product specifications and batch numbers for the impacted devices are available in the accompanying Medical Device Recall Event Report Form, reinforcing adherence to stringent medical device quality and safety standards under the NMPA's regulatory framework.