China NMPA Product Recall - Neo2® Aortic Valve, a transcatheter aortic valve delivery system.

The National Medical Products Administration (NMPA) has announced a voluntary Level III recall initiated by Boston Scientific Corporation, reported by its subsidiary, Boston Scientific International Medical Trade (Shanghai) Co., Ltd. This recall, published on November 15, 2024, pertains to two critical medical devices: the neo2® Aortic Valve and the ACURATE neo2® Transfemoral Delivery System. The basis for this action is attributed to updated instructions from the manufacturer. While the precise details of these instruction updates are not elaborated in the announcement, they have prompted the withdrawal of these transcatheter aortic valve products from the market. The "Level III" classification indicates that the use of or exposure to the affected product is unlikely to cause adverse health consequences. Operating under the NMPA's regulatory framework, this action mandates the immediate voluntary recall of the specified products. Specifics regarding the affected models, specifications, and batch numbers are comprehensively outlined in an accompanying Medical Device Recall Event Report Form. This proactive measure highlights the industry's commitment to patient safety and adherence to medical device regulations.