China NMPA Product Recall - Arterial and Venous Cannula

The National Medical Products Administration (NMPA) announced on November 13, 2024, a voluntary Class II recall initiated by Medtronic Inc. This action, reported by Medtronic (Shanghai) Management Co., Ltd. on behalf of the manufacturer, concerns Arterial and Venous Cannulas, registered under National Medical Device Registration Certificate No. 2017. The primary issue prompting the recall is identified as incorrect assembly during manufacturing. A Class II recall signifies a situation where exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Crucially, the NMPA noted that the specific products involved in this recall were not imported into China. The company is undertaking this action to ensure product quality and patient safety. Further detailed information regarding the affected models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form.