China NMPA Product Recall - Medtronic PRO+ Transcatheter Aortic Valve System

The National Medical Products Administration (NMPA) published an announcement on June 4, 2025, regarding a voluntary Class III recall initiated by Medtronic Inc. The recall pertains to its Transcatheter Aortic Valve System, specifically the Medtron PRO+ System (National Medical Device Registration Certificate No. 20243130221). Medtronic (Shanghai) Management Co., Ltd. reported this action, which was prompted by an update to the European Union's version of the product instructions. This indicates a proactive measure by Medtronic to address changes in product documentation. It is important to note that the specific products involved in this recall were not imported into the Chinese market. Therefore, the recall's immediate impact is outside China. The NMPA serves as the regulatory authority disseminating this information, ensuring transparency. Medtronic Inc. is required to execute the voluntary Class III recall, managing affected units in regions where the product was distributed and ensuring adherence to the updated instructions. Further details concerning specific models, specifications, and batch numbers are available in the "Medical Device Notice" and the "Medical Device Recall Event Report Form," providing comprehensive information for relevant stakeholders.