China NMPA Product Recall - Intra-Aortic Balloon Pump (trade name: CARDIOSAVE)

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class 3 recall for its Intra-Aortic Balloon Pumps, marketed as CARDIOSAVE. This action was reported on March 30, 2021, and falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall addresses a potential network communication interruption issue stemming from a known cybersecurity vulnerability, Ripple20. While the company confirmed that the pump's performance and patient treatment remain unaffected, and no adverse events have been reported related to this vulnerability, the proactive measure was taken. The affected devices carry CFDA Import Medical Device Registration Numbers 20143214542 and 20193082223. To facilitate the recall, Maikewei (Shanghai) Medical Equipment Co., Ltd. has provided a "Medical Device Recall Event Report Form" with detailed information on specific affected product models, specifications, and batch numbers.