# China NMPA Product Recall - Implantable deep brain stimulation extension lead, implantable spinal cord stimulation electrode, implantable spinal cord stimulation extension lead kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/b10c12e0-5c30-473d-8e31-56360e0e076b/
Source feed: China

> China NMPA product recall for Implantable deep brain stimulation extension lead, implantable spinal cord stimulation electrode, implantable spinal cord stimulation extension lead kit by Medtronic Inc. published September 15, 2023. Recall level: Level 3 Recall. On September 15, 2023, the National Medical Products Administration (NMPA) announced a voluntary Lev

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling implantable spinal nerve stimulation extension lead kits and other related products.
- Company Name: Medtronic Inc.
- Publication Date: 2023-09-15
- Product Name: Implantable deep brain stimulation extension lead, implantable spinal cord stimulation electrode, implantable spinal cord stimulation extension lead kit
- Recall Level: Level 3 Recall
- Recall Reason: Some electronic user manuals (eIFU) have not yet been published online.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On September 15, 2023, the National Medical Products Administration (NMPA) announced a voluntary Level III recall initiated by Medtronic Inc., specifically through its Chinese entity, Medtronic (Shanghai) Management Co., Ltd. The recall impacts several critical implantable medical devices, including deep brain stimulation extension leads, and various implantable spinal cord stimulation electrodes and extension lead kits. The primary reason for this action is a regulatory compliance issue: specific electronic instruction manuals (eIFUs) for these products have not yet been made available online, as required. This oversight means essential user information is not readily accessible, posing a potential concern for proper device usage. Operating under the NMPA's regulatory framework, Medtronic is undertaking this voluntary recall to address the documentation discrepancy. The required action involves removing the affected product batches from distribution. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled devices are documented in the 'Medical Device Recall Event Report Form' submitted by Medtronic, ensuring transparency and appropriate action for this significant product correction.

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