China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Level II recall for its intra-aortic balloon counterpulsation pumps, as reported by the National Medical Products Administration (NMPA) on August 11, 2017. The recall addresses critical functional and safety concerns with the medical device. The main issues identified involve the potential for condensation to accumulate within the balloon catheter. This condensation can lead to false alarms and, more critically, allow liquid to enter the pump's interior. Such liquid ingress poses a direct threat to the normal operation of the circuit board, potentially compromising the device's performance and patient safety. While specific inspection dates are not detailed in the provided document, the company proactively reported these issues and commenced the recall. The regulatory framework overseeing this action is the NMPA, which has classified it as a Level II recall, indicating a situation where the product may cause temporary or reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Maikewei (Shanghai) Medical Equipment Co., Ltd. is undertaking the required actions by recalling all affected intra-aortic balloon counterpulsation pump models, including those with registration numbers like CFDA (Imported) No. 20103213339 and 20143215339. Further comprehensive details regarding specific models, specifications, and affected batches are provided in the "Medical Device Recall Event Report Form."