China NMPA Product Recall - Cardiopulmonary bypass machine - roller pump

Maquet Cardiopulmonary GmbH is initiating a voluntary Level II recall of its cardiopulmonary machines, specifically roller pumps. The recall, reported by Maquet (Shanghai) Medical Equipment Co., Ltd. and published by the National Medical Products Administration (NMPA) on September 24, 2025, addresses a critical issue identified in India. The primary concern is the failure to regularly replace the roller pump belt, which can lead to malfunctions during the use of these vital medical devices. The affected products include specific models registered under National Medical Device Registration Certificates No. 20143453984 and 20193102214. It is important to note that the products involved in this particular recall event were not imported into China. Maquet Cardiopulmonary GmbH is taking required actions to recall the affected units, and further detailed information regarding specific models, specifications, and batches is available in the "Medical Device Recall Event Report Form" attached to the NMPA's announcement.