# China NMPA Product Recall - artificial heart valve

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/c2f31f77-f188-4880-b479-2d7ed5d48d94/
Source feed: China

> China NMPA product recall for artificial heart valve by Medtronic Inc. published July 14, 2015. Recall level: Level III. The National Medical Products Administration (NMPA) announced on July 14, 2015, details of a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. initiates voluntary recall of artificial heart valves.
- Company Name: Medtronic Inc.
- Publication Date: 2015-07-14
- Product Name: artificial heart valve
- Recall Level: Level III
- Recall Reason: Medtronic has confirmed corrective information regarding the Chinese instruction manual for its artificial heart valve (trade name: Hancock II). Specifically, some of the product standard numbers in the Chinese instruction manuals for the Hancock II artificial heart valve, approved on May 7, 2010, were incorrectly labeled as YZB/USA 1588-2005 "Hancock II Bioprosthetic Valve," while the actual product standard number registered in China should be YZB/USA 0557-2010 "Artificial Heart Valve."
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: The National Medical Products Administration (NMPA) announced on July 14, 2015, details of a voluntary Class III recall initiated by Medtronic (Shanghai) Management Co., Ltd. This recall, reported by Medtronic on May 15, 2015, involved certain artificial heart valves, specifically the Hancock II models T505 and T510. The core issue was an error in the Chinese instructions for use; the manual incorrectly displayed product standard number YZB/USA1588-2005 "Hancock II Biological Valve Prosthesis." The correct standard number, as registered in China, is YZB/USA0557-2010 "Artificial Heart Valves." This labeling discrepancy affected 16,429 units imported and sold in China. Medtronic confirmed that the artificial heart valves themselves were not defective, with the issue being solely with the accompanying documentation. Under the NMPA's regulatory framework for imported medical devices, the required actions involved replacing all incorrect Chinese instruction manuals with the accurate versions. Additionally, the company was tasked with collecting and destroying the erroneous manuals, ensuring that all products in use or distribution have the correct and compliant instructions.

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