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

On August 18, 2020, Maikewei (Shanghai) Medical Equipment Co., Ltd. announced a voluntary Class II recall concerning its Cardiopulmonary Bypass Heat Exchanger (HPL). This critical action, published under the authority of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, was initiated following multiple customer complaints. The primary issue identified was leakage from the vacuum valve within the heat exchanger/cardiopulmonary bypass heat exchanger of specific HCU40 cardiopulmonary bypass machines. To uphold its commitment to customer responsibility and to ensure the continued safety and efficacy of its medical devices, Maikewei (Shanghai) Medical Equipment Co., Ltd. chose to recall the potentially affected products. These include the artificial heart-lung machine heat exchange water tank and the heart-lung bypass heat exchange water tank, registered under CFDA Imported Medical Device Registration No. 20142452038 and CFDA Import Registration No. 20182451979. The recall aims to effectively eliminate any potential safety hazards that could arise from the reported vacuum valve leakage. Despite the seriousness of the defect, the manufacturer confirmed that no adverse events directly related to this specific issue had been reported at the time of the recall. Comprehensive details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form," which guides the required actions for addressing this product quality concern.