China NMPA Product Recall - Ureteral stent tube

Shanghai Innovate Medical Devices Co., Ltd. initiated a voluntary Class III recall of its ureteral stents (model: IVX-UT-01-472610, batch number: 201214-UT). This action, published by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 27, 2021, was prompted by the discovery that the fixation strength test results for the affected batch did not meet the company's established technical requirements. While specific inspection dates are not provided, the issue was identified through internal testing. The primary violation centers on a critical quality defect where the device's ability to maintain its intended position failed to meet safety and performance standards. Operating under the regulatory oversight of the NMPA, the company's required action is to remove the non-conforming products from the market to ensure patient safety and adherence to medical device regulations. A Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information on the recalled products is available in the associated "Medical Device Recall Event Report Form."