China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary recall of its intra-aortic balloon counterpulsation pumps, as announced by the National Medical Products Administration (NMPA) on July 14, 2017. The recall addresses a critical product defect where the solenoid valve drive circuit board may exhibit insufficient power output. This deficiency can cause the solenoid valve to fail to open, potentially leading to an interruption or delay in vital patient treatment.

The affected devices include models with registration numbers CFDA (Imported) No. 20103213339 and CFDA (Imported) No. 20103213356. While specific inspection dates are not provided in this recall notice, the company's proactive measure falls under the regulatory purview of the NMPA. Maikewei (Shanghai) Medical Equipment Co., Ltd. has taken the required action of a voluntary recall to address this significant safety concern. Further detailed information, including specific models, specifications, and batch numbers of the affected products, is available in the 'Medical Device Recall Event Report Form' submitted by the company. This action underscores the commitment to patient safety and adherence to medical device regulations.