China NMPA Product Recall - Products such as heart valve repair rings

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Edwards Lifesciences LLC, effective July 31, 2025. This action stems from identified discrepancies found on a limited number of "patient implantation cards" associated with several of their medical devices. The affected products include various heart valve annuloplasty rings, annuloplasty systems, and pericardial bioprostheses, specifically those with National Medical Device Registration Certificates such as the Annuloplasty Ring, Tricuspid Annuloplasty Ring, Pericardial Bioprosthesis, Edwards Inspiris Resilia Aortic Valve, and Mitris Resilia Mitral Valve. Edwards Lifesciences LLC, through its Shanghai subsidiary, proactively reported this measure to the NMPA. Notably, the specific product batches involved in this recall were not imported into the Chinese market. Detailed information concerning models, specifications, and batch numbers is available in the official Medical Device Recall Event Report Form, underscoring the company's commitment to maintaining product integrity and ensuring patient safety under NMPA oversight.