# China NMPA Product Recall - Intrathecal catheter, drug infusion system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/3b512751-df4c-4390-a445-06bd88bab6c9/
Source feed: China

> China NMPA product recall for Intrathecal catheter, drug infusion system by Medtronic Inc. published July 31, 2025. Recall level: Level 3 Recall. Medtronic Inc. initiated a voluntary Class III recall of specific intrathecal catheters and drug inf

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its intrathecal catheters and drug infusion systems.
- Company Name: Medtronic Inc.
- Publication Date: 2025-07-31
- Product Name: Intrathecal catheter, drug infusion system
- Recall Level: Level 3 Recall
- Recall Reason: The product's electronic manual was not translated using the correct version; the "Intended Users" and "Storage" sections are missing some information.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary Class III recall of specific intrathecal catheters and drug infusion systems, as announced by the National Medical Products Administration (NMPA) on July 31, 2025. The recall was prompted by an error in the product's electronic instruction manual, where an incorrect translation resulted in missing crucial information within the "Intended User" and "Storage" sections. Medtronic (Shanghai) Management Co., Ltd. reported this issue. It is important to note that the affected products involved in this recall were not imported into China. The regulatory action underscores the importance of accurate product documentation in ensuring patient safety and proper device usage. Further details regarding specific locations and batch numbers are available in the attached Medical Device Recall Event Report Form.

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