China NMPA Product Recall - Cordis S.M.A.R.T.® Flex Nickel-Titanium Support System

The National Medical Products Administration (NMPA) published a notice on March 17, 2017, regarding a voluntary, Level II recall initiated by Contis (Shanghai) Medical Devices Co., Ltd., a subsidiary of Cordis, a Cardinal Health company. This recall involves specific models of their S.M.A.R.T.® Flex Nickel-Titanium Stent System, notably SF05200MV, SF05200SV, SF06200MV, and SF06200SV. The primary reason for this action is a reported elevated incidence of stent release difficulties or complete failures during use, as evidenced by global complaints. Operating within the NMPA's medical device regulatory framework, Contis (Shanghai) Medical Devices Co., Ltd. formally reported the issue on February 23, 2017, and began implementing corrective measures. The required actions include a global recall of all affected product batches. In China, 57 imported units were specifically targeted. The company is actively notifying all distributors and customers to ensure the retrieval of any unused products, reinforcing patient safety and adherence to medical device standards. This proactive, voluntary recall highlights the manufacturer's dedication to resolving product performance concerns swiftly.