# China NMPA Product Recall - Heart Suction Tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/90bd8ed8-198d-481e-ac2d-365acb45acf4/
Source feed: China

> China NMPA product recall for Heart Suction Tube by Medtronic Inc. published October 21, 2025. Recall level: Level 1 Recall. Medtronic, Inc., in conjunction with its subsidiary Medtronic (Shanghai) Management Co., Ltd., has i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. is voluntarily recalling its Heart Suction Tube.
- Company Name: Medtronic Inc.
- Publication Date: 2025-10-21
- Product Name: Heart Suction Tube
- Recall Level: Level 1 Recall
- Recall Reason: Subsidiary supplier changes to stainless steel wire production process
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic, Inc., in conjunction with its subsidiary Medtronic (Shanghai) Management Co., Ltd., has issued a voluntary recall of its Heart Suction Tubes (National Medical Device Registration No. 20152141672). This action was initiated due to a critical change in the production process of stainless steel wire by a secondary supplier. The issue was initially reported to the Shanghai Municipal Drug Administration on August 27, 2025, as a Class II recall (Shanghai Medical Device Main Recall 2025-164). Although the recall was initially communicated as being reclassified to a Class I recall, Medtronic, Inc. subsequently clarified that its voluntary recall of the affected Heart Suction Tubes is not a Class I recall. The National Medical Products Administration (NMPA) published this recall information on October 21, 2025. The recall encompasses specific product models, specifications, and batches, with detailed information available in the "Medical Device Recall Event Report Form" provided as an attachment. This proactive measure by Medtronic underscores its commitment to product safety and compliance with regulatory standards. The company is taking necessary steps to address the supplier-related manufacturing deviation to ensure the continued integrity and performance of its medical devices. Affected parties are advised to refer to the comprehensive recall report for specific guidance.

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