China NMPA Product Recall - artificial heart valve

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.