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 system, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on March 2, 2021. The recall addresses an issue with certain product batches manufactured between October 2019 and August 2020. The primary problem identified was insufficient adhesion, which led to the detachment of the delivery system tip in a small number of cases. This defect posed a potential risk during medical procedures. Following the identification of the issue, Contis (Shanghai) Medical Devices Co., Ltd. implemented corrective measures to prevent recurrence in subsequently manufactured products. The voluntary recall signifies the company's commitment to product safety and compliance with regulatory standards. Affected products are detailed in the "Medical Device Recall Event Report Form," indicating the specific models, specifications, and batches subject to this action. This recall highlights the stringent oversight by Chinese regulatory bodies, ensuring that medical devices meet established quality and safety criteria.