# China NMPA Product Recall - Implantable Neurostimulation Lead

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/1807f4b1-c7dd-4556-aee1-5c2b8e34e07d/
Source feed: China

> China NMPA product recall for Implantable Neurostimulation Lead by Medtronic Inc. published July 27, 2021. Recall level: Level 1 Recall. Medtronic Inc. initiated a voluntary Class I recall for specific batches of its implantable neurosti

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its Neurostimulation Lead implantable neurostimulation electrode.
- Company Name: Medtronic Inc.
- Publication Date: 2021-07-27
- Product Name: Implantable Neurostimulation Lead
- Recall Level: Level 1 Recall
- Recall Reason: Due to a manufacturing issue, in certain batches of StimLoca drill caps, the support clip edge may exhibit an additional protrusion that could affect the product's normal use and performance.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary Class I recall for specific batches of its implantable neurostimulation lead electrodes. This action, documented by the National Medical Products Administration (NMPA) under Index No. JGXX-2021-10411 and published on July 27, 2021, addresses a critical manufacturing defect. The issue stems from certain StimLoca drill caps, which were found to possess an additional protrusion on the edge of the support clip. This flaw could significantly impede the product's normal functionality and compromise its performance. The recall pertains to the implantable neurostimulation lead electrode (Registration Certificate No. 20163212970). Medtronic (Shanghai) Management Co., Ltd. reported this defect, prompting the NMPA to classify it as a Class I recall, signifying a high potential for serious adverse health consequences. Detailed information regarding affected product models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form." Medtronic is taking this proactive step to uphold product quality and patient safety.

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