China NMPA Product Recall - Heart rhythm management device Programmer

Medtronic, Inc., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class III recall of its Programmer for Heart Rhythm Management Device. This action, reported by the National Medical Products Administration (NMPA) on November 29, 2024, is due to an 'error update prompt' identified in the device, registered under National Medical Device Registration No. 20242120424. While the recall is a global initiative by the manufacturer, Medtronic, Inc., it's important to note that the specific products subject to this recall were not imported into the Chinese market. The regulatory oversight for this event falls under the NMPA's framework for medical device safety. The required action involves the manufacturer's voluntary retrieval of the affected devices to address the identified issue, ensuring the integrity and safe operation of the heart rhythm management programmers. Further specifics on affected models and batches are detailed in the accompanying Medical Device Recall Event Report Form.