China NMPA Product Recall - Nickel-titanium support system

Contis (Shanghai) Medical Devices Co., Ltd., a subsidiary of Cardinal Health's Cordis, initiated a Level II voluntary recall of its S.M.A.R.T. Flex Nickel-Titanium Stent Systems. The company formally reported this action to the National Medical Products Administration (NMPA) on February 23, 2017, with the NMPA publishing the notification on April 6, 2017. The recall was prompted by reports indicating a higher-than-expected incidence of stent release difficulties or failures during the use of specific models. Affected products include the SF05200MV and SF06200MV stent systems, designed for treating atherosclerotic lesions in various arteries. The identified issue posed a potential risk during implantation procedures. Operating under the NMPA's regulatory framework for medical device safety, Contis (Shanghai) Medical Devices Co., Ltd. took swift corrective action. The recall impacts products globally, with 57 units specifically imported into China across nine distinct batches. The company's required actions involved notifying all affected distributors and customers in China to promptly identify and return any unused recalled products, ensuring they are removed from circulation to prevent further incidents. This proactive measure underlines the company's commitment to patient safety and adherence to regulatory standards.