China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its intra-aortic balloon counterpulsation pump. This action, publicized on October 18, 2018, by the National Medical Products Administration (NMPA), addresses a critical product deficiency. The primary issue identified is that the medical device may malfunction when used at altitudes exceeding 975 meters, potentially interrupting patient treatment and causing unstable blood flow. This recall adheres to the NMPA's regulatory framework for medical devices, with the company taking the required action to voluntarily withdraw the affected product from the market. The specific details, including product type and batch numbers, are provided in the accompanying "Medical Device Recall Event Report Form." This ensures patient safety by removing a potentially problematic device under specific environmental conditions.