# China NMPA Product Recall - Implantable Deep Brain Stimulation Pulse Generator Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/794ad29a-9cbc-45b3-aa73-8a56f46284ea/
Source feed: China

> China NMPA product recall for Implantable Deep Brain Stimulation Pulse Generator Kit by Medtronic Inc. published August 23, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is issuing a voluntary recall for its implantable deep brain stimulation (DBS) pulse generator kits.
- Company Name: Medtronic Inc.
- Publication Date: 2024-08-23
- Product Name: Implantable Deep Brain Stimulation Pulse Generator Kit
- Recall Level: Level 2 Recall
- Recall Reason: Using a specific model of stimulator can cause problems with the programmable controller display.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Medtronic Inc. for its Implantable Deep Brain Stimulation (DBS) Pulse Generator Kits. This action, reported by Medtronic (Shanghai) Management Co., Ltd. on August 23, 2024, addresses an identified problem with the programmable controller display when used with a specific stimulator model. This issue has the potential to impact the device's functionality or safe operation. While Medtronic Inc. is the manufacturer, it is important to note that the specific products involved in this recall were not imported into the Chinese market. Operating under the NMPA's regulatory framework, Medtronic is undertaking this voluntary measure to proactively resolve the device anomaly. The required actions primarily involve the recall of affected DBS kits, with comprehensive details regarding specific models, specifications, and affected product batches available in the official 'Medical Device Recall List' and the 'Medical Device Recall Event Report Form' submitted by Medtronic (Shanghai) Management Co., Ltd.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/