China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd., acting as the agent for manufacturer Datascope Corp., initiated a voluntary Class II recall of 646 units of their intra-aortic balloon counterpulsation pumps (models CS100 and CS300) in China. This global recall, reported on June 23, 2017, and published by the National Medical Products Administration (NMPA) on August 8, 2017, addresses a critical technical issue. The main violation identified is insufficient output power from the solenoid valve drive circuit board, which can cause the solenoid valve to fail to open. This defect carries significant patient safety implications, potentially leading to the interruption or delay of vital circulatory support treatment. Under the NMPA's regulatory framework, Maikewei (Shanghai) Medical Equipment Co., Ltd. is required to issue formal "Medical Device Recall Notices" to all affected customers. Furthermore, the company must replace the defective solenoid valve drive circuit board free of charge for all impacted products to ensure proper device functionality and mitigate potential patient harm.