China NMPA Product Recall - Implantable Left Ventricular Assist System

Abbott Medical Products (Shanghai) Co., Ltd., on October 29, 2025, initiated a voluntary Class I recall of its Implantable Left Ventricular Assist System (National Medical Device Registration Certificate No. 20243120384). This recall, overseen by the National Medical Products Administration (NMPA), addresses a critical product issue. The primary concern is that excessive handling of the ribbon cable connection interface can potentially trigger a backup battery alarm within the system controller. This defect poses a significant risk, leading to the highest level of recall to ensure patient safety. Abbott Medical Products is proactively taking steps to address this manufacturing concern, with detailed information regarding the affected product models, specifications, and batch numbers available in the attached Medical Device Recall Event Report Form. The company's immediate action underscores its commitment to regulatory compliance and patient well-being, necessitating the prompt removal of affected devices from the market to mitigate potential adverse events.