China NMPA Product Recall - Implantable rechargeable spinal cord stimulator

Medtronic Inc. and its subsidiary, Medtronic (Shanghai) Management Co., Ltd., have initiated a voluntary Class II recall of specific implantable rechargeable spinal cord stimulators (Phase 20203120514). This action, publicly announced on April 25, 2024, by the National Medical Products Administration (NMPA), addresses a critical product issue. The primary concern stems from the potential for incorrect selection of the "non-Medtronic" lead configuration option during device setup or use, which could impact the stimulator's intended performance and patient safety. While no specific inspection dates were provided, the company's proactive voluntary recall demonstrates its adherence to medical device safety standards under the NMPA's regulatory framework. The required action involves the systematic removal of all affected models, specifications, and batches from distribution. Detailed information regarding the scope of the recall and necessary procedures for healthcare providers and patients is available in the associated "Medical Device Recall Event Report Form."