China NMPA Product Recall - Neuromodulation device programmer, spinal cord nerve stimulator doctor programming system, patient programmer

Medtronic Inc., via its Medtronic (Shanghai) Management Co., Ltd. entity, has initiated a voluntary Level II recall of specific neuromodulation device programmers and spinal neurostimulator physician programming systems. This action, publicly released by the National Medical Products Administration (NMPA) on September 15, 2023, addresses a critical software incompatibility. The issue arises because an updated A710 CP application (v2.0.136) cannot properly communicate with implantable and wireless external neurostimulators (INS/WENS) due to its incompatibility with the existing A901 Communication Manager application (v1.0.1169). This technical conflict prevents the devices from functioning as intended. The affected products include the spinal cord stimulator physician programming system, physician programming device, and neuromodulation device programming device, all operating under NMPA medical device registration. Medtronic is taking this voluntary action within the NMPA's regulatory guidelines. The immediate required action is the recall of these devices to prevent potential patient safety risks associated with communication failures, with detailed product information available in the attached recall report.