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

Medtronic Inc. has initiated a voluntary Level II recall for its spinal nerve stimulator physician programming system, identified under National Medical Device Registration Certificate No. 20202120339. This significant action, publicly reported by Medtronic (Shanghai) Management Co., Ltd. and published by the National Medical Products Administration (NMPA) on December 20, 2023, addresses a critical product anomaly. The recall stems from the discovery that when the nerve stimulator (INS) is programmed using the A71100 Restorel Clinic Programmer Application (Restore-CP-App), its screen erroneously displays an "INS in the box" message. This specific software issue has prompted Medtronic to proactively recall the affected physician programming systems to mitigate any potential impact on device functionality or the accuracy of information displayed to medical professionals. A Level II recall indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Medtronic (Shanghai) Management Co., Ltd. has provided detailed information regarding the affected product models, specifications, and batch numbers within the "Medical Device Recall Event Report Form," which serves as the official documentation for this event. This voluntary recall emphasizes Medtronic's dedication to ensuring the safety, reliability, and regulatory compliance of its medical devices, maintaining trust within the healthcare community and protecting patient well-being.