China NMPA Product Recall - Nickel-titanium support system

Condis (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary Level II recall for specific batches of its nickel-titanium stent system. This action, publicly disclosed by the National Medical Products Administration (NMPA) on October 12, 2021, addresses significant quality deficiencies discovered during a supplier's product qualification inspection. The affected stent products were manufactured before August 23, 2021. The primary issues identified include insufficient adhesion at the delivery system tip, which could lead to its displacement or detachment during use. Additionally, these batches failed to meet the specified tensile strength requirements, indicating a potential compromise in the device's structural integrity and performance. Under the NMPA's regulatory framework, Condis is taking proactive steps to remove these non-conforming products from the market. Detailed information regarding the models, specifications, and batch numbers of the recalled devices is provided in the "Medical Device Recall Event Report Form," accessible through the NMPA website. This recall underscores a commitment to patient safety and adherence to regulatory standards.