# China NMPA Product Recall - artificial heart valve

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/9e0d7a92-642d-4da6-97cb-0a0ff742bee5/
Source feed: China

> China NMPA product recall for artificial heart valve by Medtronic (Shanghai) Management Co., Ltd. published March 02, 2020. Recall level: Level 2 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its artificial he

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls artificial heart valves.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2020-03-02
- Product Name: artificial heart valve
- Recall Level: Level 2 Recall
- Recall Reason: We received a complaint from a customer regarding an incorrect English label. The label displayed "Aortic" but should have read "Mitral". Our investigation suggests the error was likely caused by human error during the label printing process.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its artificial heart valves (Registration Certificate No.: 20183461518), publicly announced on March 2, 2020, by the National Medical Products Administration (NMPA). The recall stemmed from customer complaints identifying an incorrect English label on the product, which displayed "Aortic" where "Mitral" was appropriate. Investigation by Medtronic suggested this labeling discrepancy was likely due to human error during the printing process. Notably, the Chinese label content was correct, and no other product issues were identified. The company received only one complaint from within China, with no patient involvement or reported injuries. This proactive measure, reported through the Shanghai Municipal Drug Administration, reflects Medtronic's commitment to product accuracy and regulatory compliance. The required action involves the retrieval of affected artificial heart valve batches, with detailed information available in the accompanying "Medical Device Recall Event Report Form," to ensure all products bear correct and consistent labeling.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/