China NMPA Product Recall - Implantable left ventricular assist system

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Abbott Medical Products (Shanghai) Co., Ltd., effective July 10, 2025. This recall specifically targets Abbott Medical's Implantable Left Ventricular Assist System. The central issue identified is a potential defect where the AC power cord of the portable power supply device in some units may not fully lock into its receptacle when inserted. This flaw could lead to an unexpected loss of power, which is critical for the continuous operation of this life-sustaining medical device. The NMPA, as the authoritative regulatory body in China, classified this action as a Class II recall. Abbott Medical Products is taking this proactive measure to address the potential safety concern. It is important to note that, despite the recall announcement by the NMPA, the particular products affected by this recall were not imported or distributed within the Chinese market. Further specific details, including involved models, specifications, and approval information, are accessible through the "Medical Device Recall Event Report Form" provided by the manufacturer. This action highlights the company's commitment to product safety and regulatory compliance.