China NMPA Product Recall - Centrifugal Pump System

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by LivaNova Deutschland GmbH for its Centrifugal Pump System (Registration Certificate No.: 20173456739). This action, reported by LivaNova (China) Medical Technology Co., Ltd., stems from the discovery that a critical magnetic ring may be missing from specific models and batches of the devices. The recall was announced on July 18, 2022. The primary issue identified is a manufacturing defect where an essential component, the magnetic ring, was not installed as required in certain units. This omission could potentially impact the proper functioning of the Centrifugal Pump System, a medical device. The specific models, specifications, and batch numbers of the affected products are detailed in an accompanying "Medical Device Recall Event Report Form." Operating under the oversight of the NMPA, China's national regulatory body for medical devices, LivaNova Deutschland GmbH is taking proactive steps to address this quality control issue. A Class III recall indicates that the use of, or exposure to, a violative product is not likely to cause adverse health consequences. The voluntary recall ensures that potentially defective devices are removed from circulation to safeguard patient safety and maintain product integrity, aligning with NMPA's regulatory standards.