China NMPA Product Recall - Disposable nerve stimulation probe

Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class III recall of specific single-use neurostimulation probes, as reported on January 18, 2019. The recall was prompted by a classification discrepancy in the European market. It was determined that certain disposable neurostimulation probes, including models BNP2001 and BNP2002, were not correctly classified as Class III medical devices under Article 6 of the European Medical Device Directive (MDD). The issue necessitated a reclassification to the appropriate Class III designation. Corrective actions are exclusively focused on the European market, covering countries such as France and Italy. Medtronic is adjusting the product classification and will provide product safety notices to customers who have acquired the affected devices in those regions. Crucially, the recall document specifies that this issue and the required corrective measures do not extend to the Chinese market, meaning no actions are mandated for products in China.