China NMPA Product Recall - Implantable neurostimulation electrodes

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its implantable neurostimulation electrodes, as publicly reported by the National Medical Products Administration (NMPA) on May 8, 2017. The core issue prompting this recall is a manufacturing deficiency where the depth stop gauge screw possesses insufficient thread length. This defect could cause the electrode to slide unexpectedly within the depth stop gauge, posing potential risks to device functionality and patient safety. A Class II recall, as designated by regulatory bodies, signifies that the product's use might lead to temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. Medtronic (Shanghai) is undertaking this action to address the identified problem. Further specific information regarding the affected product models, their specifications, and batch numbers can be found in the accompanying "Medical Device Recall Event Report Form" attachments. This proactive measure by Medtronic (Shanghai) demonstrates compliance with NMPA's regulatory framework and commitment to patient safety standards.