China NMPA Product Recall - Implantable Deep Brain Stimulation Pulse Generator Kit

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Medtronic Inc. for its Implantable Deep Brain Stimulation (DBS) Pulse Generator Kits. This action, reported by Medtronic (Shanghai) Management Co., Ltd. on August 23, 2024, addresses an identified problem with the programmable controller display when used with a specific stimulator model. This issue has the potential to impact the device's functionality or safe operation. While Medtronic Inc. is the manufacturer, it is important to note that the specific products involved in this recall were not imported into the Chinese market. Operating under the NMPA's regulatory framework, Medtronic is undertaking this voluntary measure to proactively resolve the device anomaly. The required actions primarily involve the recall of affected DBS kits, with comprehensive details regarding specific models, specifications, and affected product batches available in the official 'Medical Device Recall List' and the 'Medical Device Recall Event Report Form' submitted by Medtronic (Shanghai) Management Co., Ltd.