China NMPA Product Recall - Nickel-titanium support system

Contis (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Nickel-Titanium Stent Systems, as announced by the National Medical Products Administration (NMPA) on March 17, 2017. The company discovered a significant performance issue where certain products exhibited "release difficulties or failures," which could potentially impact patient safety and the effectiveness of the device during medical procedures. This proactive measure by Contis Shanghai aligns with the stringent regulatory framework of the NMPA, China's primary authority for medical products. The recall, stemming from the company's internal quality surveillance, did not specify external inspection dates but rather the firm's self-identification of the issue. As part of the required actions, Contis Shanghai is actively retrieving the affected Nickel-Titanium Stent Systems from the market. The specific models and specifications included in this recall are comprehensively detailed in the official "Medical Device Recall Event Report Form." This action aims to prevent further use of the non-conforming devices and mitigate potential risks to patients, ensuring adherence to product safety standards.