China NMPA Product Recall - Intra-aortic balloon catheter and accessories

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its intra-aortic balloon catheters and accessories, as reported by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration on August 7, 2020. The recall pertains to products manufactured between February 3, 2017, and February 21, 2020. The primary issue identified was that functional tests conducted on a small number of samples from each batch, prior to sterilization, indicated that endotoxin levels might not comply with AAMI ST72 requirements. This potential non-compliance presents a significant health risk, particularly for vulnerable patients with severe cardiopulmonary conditions and compromised immune systems. In response to this safety concern, the company is recalling affected intra-aortic balloon catheters and accessories, registered under certificate numbers 20163770667, 20153772355, and 20183771789. The company's action demonstrates a commitment to customer safety and product efficacy. Further specific details regarding models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form.