China NMPA Product Recall - Basix Touch Inflation Device - Inflation Pump System

Merit Medical Systems, Inc. initiated a voluntary recall of specific models and batches of its Basix Touch Inflation Device, as announced by the National Medical Products Administration (NMPA) on April 12, 2022. The recall was prompted by a design change that created an internal gap within the rotary Y-valve body of the hemostatic valve. This critical issue could impede the advancement of guidewires, potentially affecting patient procedures and safety. Merit Medical Devices (Beijing) Co., Ltd. reported the issue, leading to the manufacturer, Merit Medical Systems, Inc., taking action. The recall, whose specific level was not detailed, falls under the regulatory oversight of the NMPA. The required action involves the voluntary recall of the affected devices (Registration Certificate No.: 20183662068), with detailed information on specific models, specifications, and batches provided in an attached Medical Device Recall Event Report Form.