China NMPA Product Recall - Artificial heart-lung machine - heat exchange water tank; heart-lung bypass heat exchange water tank

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall for its Cardiopulmonary Bypass Heat Exchanger (CPR Heat Exchanger), specifically the HCU40 model, and associated artificial heart-lung machine (ECL) heat exchange water tanks. This action, publicly announced on October 12, 2020, through the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, addresses a critical product safety concern. The company received complaints detailing overheating damage to the insulation layer of the connecting wire joint, located between the main power switch and the power filter within the HCU40 units. Although no adverse events directly related to the power switch or internal wiring issues have been reported to date, Maikewei (Shanghai) Medical Equipment Co., Ltd. proactively decided to recall affected products to mitigate potential hazards. The recall specifically covers devices under registration certificates CFDA Import Registration No. 20142452038 and CFDA Import Registration No. 20182451979, with detailed model, specification, and serial number information available in the official Medical Device Recall Event Report Form. This recall emphasizes the company's commitment to product safety under the regulatory oversight of Chinese health authorities.