China NMPA Product Recall - Intra-aortic balloon counterpulsation pump (brand name: CARDIOSAVE)

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class I recall, updated on July 29, 2019, for its Intra-Aortic Balloon Counterpulsation Pump (CARDIOSAVE) due to a critical battery performance issue. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses inconsistencies in battery runtime and discharge cycles across various IABP models. The primary concern is that if users do not strictly follow the operating instructions for battery use, charging, maintenance, and storage, the device may provide less runtime than expected when operating on battery power. This could pose a significant safety risk in clinical environments. As a required action, the company is proactively informing all customers to adhere meticulously to the battery maintenance recommendations outlined in the device's operating instructions. The recall impacts specific product models, specifications, and batches, underscoring the manufacturer's commitment to patient safety and device reliability.