China NMPA Product Recall - artificial heart valve

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.