China NMPA Product Recall - Clinician Programmer System for DBS Neurostimulator

Medtronic Inc. initiated a voluntary Class II recall of its Clinician Programmer System for DBS Neurostimulator, as announced by the National Medical Products Administration (NMPA) on January 13, 2023. This action, reported by Medtronic (Shanghai) Management Co., Ltd., addresses a critical software issue. The main violation identified is a defect in the parsing code responsible for handling the last page of the system log within the software of specific product models and batches. The affected device, registered under certificate No. 20192120588, is a key component for deep brain stimulation neurostimulators. While specific inspection dates are not provided in the recall notice, the regulatory framework governing this action is the NMPA, with the Class II designation indicating a potential for temporary or medically reversible adverse health consequences, or a remote probability of serious adverse health consequences. Medtronic's required action involves retrieving the affected Clinician Programmer System from the market to mitigate any potential risks associated with the software flaw. Further details regarding specific products and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This recall highlights the company's commitment to ensuring the safety and reliability of its medical devices.