China NMPA Product Recall - Spinal cord nerve stimulator doctor programming system

On December 21, 2020, the National Medical Products Administration (NMPA) announced that Medtronic Inc., facilitated by its subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Level II recall for specific models and batches of its spinal nerve stimulator physician programming system. The primary issue necessitating this action is a software problem that prevents users from successfully upgrading the equipment. This malfunction could hinder the device's functionality or prevent essential updates. Operating under the regulatory oversight of the NMPA, Medtronic proactively undertook this recall to address the identified product deficiency. The required action involves the retrieval of all affected stimulator physician programming systems, identified by Registration Certificate No.: 20202120339. Detailed information regarding the involved models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report." This measure ensures that devices with the critical software defect are removed from circulation, prioritizing patient safety and maintaining product integrity within the medical device market.