China NMPA Product Recall - Nickel-titanium support system

The National Medical Products Administration (NMPA) announced a Level II voluntary recall initiated by Contis (Shanghai) Medical Devices Co., Ltd., on behalf of its manufacturer, Cordis Cashel, a Cardinal Health company. This recall, reported on February 23, 2017, pertains to specific models of the S.M.A.R.T. Flex Nickel-Titanium Stent System, including part numbers SF05200MV and SF06200MV, along with their variants. The primary issue driving this action is a reported higher incidence of stent release difficulties or failures observed globally during the use of these affected products, which could potentially compromise patient treatment by hindering proper stent deployment. In response to these critical findings, Contis (Shanghai) Medical Devices Co., Ltd. has initiated the recall of 57 affected units imported into China, encompassing nine specific product batches. The company is required to notify all affected distributors and customers to ensure the prompt retrieval of any unused products. This measure is crucial for mitigating potential patient risks and upholding product safety standards.