China NMPA Product Recall - Vascular Prostheses

On June 17, 2022, the National Medical Products Administration (NMPA) announced a Class III voluntary recall concerning Vascular Prostheses manufactured by InterVascular SAS (Intel Vanscolex Co., Ltd.). The recall was prompted by a report submitted by Maikewei (Shanghai) Medical Equipment Co., Ltd., highlighting critical errors in the product labeling information for specific models and batches of the devices. These labeling inaccuracies could potentially mislead users regarding product specifications or usage, underscoring the importance of precise medical device information for patient safety. The affected products are identified by Registration Certificate No.: 20183461812. As a voluntary action under the regulatory framework of the NMPA, InterVascular SAS is undertaking this recall to rectify the identified discrepancies. The Class III designation indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information, including specific product models, specifications, and affected batches, is documented in the "Medical Device Recall Event Report Form" attached to the official notice. This proactive measure by the manufacturer demonstrates a commitment to upholding regulatory standards and ensuring the reliability of their medical devices.