China NMPA Product Recall - Programmable charging kit

Medtronic Inc., in collaboration with its subsidiary Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its programmable charging kits. This action, reported on November 17, 2023, to the National Medical Products Administration (NMPA), was prompted by an internal finding during incoming material inspection. It was discovered that some programmable controllers within the kits lacked the correct firmware necessary to support the Japanese user interface. This significant oversight presents a potential risk, as it may cause communication problems with implanted neurostimulators (INS), thereby compromising device functionality. The Class II recall indicates a situation where the use of or exposure to the affected product could lead to temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Medtronic is taking the required actions to address the specific affected product models, specifications, and batches, as detailed in the accompanying Medical Device Recall Event Report Form, adhering to the NMPA's regulatory requirements.