China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a Level 2 global recall for its Intra-Aortic Balloon Counterpulsation Pumps, specifically models CS100 and CS300. The recall was reported to the National Medical Products Administration (NMPA) on June 23, 2017, with public notification on July 27, 2017. The core issue identified is insufficient output power from the solenoid valve drive circuit board, which can prevent the solenoid valve from opening. This defect poses a risk of treatment interruption or delay for patients relying on these temporary circulatory support devices. Approximately 650 affected units were imported into China, with 646 already distributed. As required by the NMPA, Maikewei (Shanghai) Medical Equipment Co., Ltd. is issuing a formal recall notice to customers and will provide free replacement of the faulty solenoid valve drive circuit boards to rectify the issue and ensure the continued safe operation of the devices.