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

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall on July 3, 2019, for its Intra-Aortic Balloon Counterpulsation Pump (IABP), specifically models branded "CARDIOSAVE." The core issue stems from variations in battery runtime and discharge cycles across different IABP models. The company identified that if users do not strictly follow the battery usage, charging, maintenance, and storage guidelines outlined in the device’s operating instructions, the IABP may provide less than the expected minimum runtime when operating on battery power. This proactive measure falls under the regulatory purview of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. As part of this recall, Maikewei is proactively instructing all IABP users to meticulously adhere to the recommendations provided in the device’s operating instructions regarding battery management. This action is crucial to ensure consistent and safe device performance. Further comprehensive details concerning the specific affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."