# China NMPA Product Recall - Disposable nerve stimulation probe

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-xomed-inc/4b414f38-566d-4e6c-99e5-084f251b2d6e/
Source feed: China

> China NMPA product recall for Disposable nerve stimulation probe by Medtronic Xomed, Inc. published January 30, 2019. Recall level: Level 3 Recall. Medtronic Xomed, Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a volu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Xomed, Inc. is actively recalling single-use neurostimulation probes.
- Company Name: Medtronic Xomed, Inc.
- Publication Date: 2019-01-30
- Product Name: Disposable nerve stimulation probe
- Recall Level: Level 3 Recall
- Recall Reason: Our company has discovered that, according to Article 6 of the European Medical Device Directive (MDD), the disposable neurostimulation probes with models BNP2001 and BNP2002 should be classified as Class III (i.e., Class 3 medical devices), but have been incorrectly classified as Class 1a (i.e., Class 2a medical devices) in Europe. Therefore, we are only correcting the error in the European market, reclassifying the products as Class III (i.e., Class 3 medical devices), and issuing product safety notices to customers who have already sold these products.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Xomed, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-xomed-inc/6ab04f9c-4587-45b0-ab74-0dfb3aa38e32/