China NMPA Product Recall - Mosaic Porcine Bioprosthesis (a porcine bioprosthetic valve) and Hancock II Porcine Bioprosthesis (an artificial heart valve)

Medtronic Inc., through its Medtronic (Shanghai) Management Co., Ltd. affiliate, initiated a voluntary Class III recall on July 1, 2019, for its Mosaic Porcine Bioprosthesis and Hancock II Porcine Bioprosthesis (Artificial Heart Valve). The primary issue identified was a discrepancy between the packaging label size and the actual product dimensions. This recall falls under the regulatory purview of the National Medical Products Administration (NMPA) of China, which oversees medical device registrations and recalls. While specific inspection dates were not detailed, this action represents a proactive measure by the manufacturer to address a packaging inconsistency for products holding valid National Medical Device Registration Certificates. As part of the required actions, Medtronic is expected to provide comprehensive information regarding the affected products and specific batch numbers in an attached "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product quality and compliance within the NMPA's regulatory framework.