China NMPA Product Recall - Heart rhythm management device Programmer

Medtronic, Inc., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its Heart Rhythm Management Device Programmer. The recall, announced on August 7, 2025, addresses two primary concerns impacting product safety and user comprehension. Firstly, the device may display inaccurate electrical reset messages, potentially leading to incorrect operational interpretations. Secondly, the instruction manual lacks clear explanation regarding the purpose and applicable conditions of the "stop" button, which could easily cause user misunderstanding and confusion during critical use. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China, as indicated by the NMPA index. The company is taking proactive steps to address these issues to ensure patient safety and device efficacy. Specific details regarding affected models and batches are provided in the accompanying "Medical Device Recall Event Report Form" attachment, guiding users and healthcare professionals on the necessary actions to take in response to this recall.