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

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for its Intra-Aortic Balloon Pump, sold under the trade name CARDIOSAVE. This recall was announced on November 24, 2021, by the Shanghai Drug Administration and reported by the National Medical Products Administration (NMPA).

The primary concern leading to this action is the potential for external liquids, such as saline, to leak into the device. If these liquids penetrate the internal circuit board, it could cause a malfunction in the circuit, thereby impairing the critical counterpulsation therapy the device provides. The recall applies to specific models, specifications, and batch numbers detailed in the accompanying Medical Device Recall Event Report Form.

Maikewei (Shanghai) Medical Equipment Co., Ltd. is undertaking this action to mitigate the identified safety risk, ensuring adherence to regulatory standards and patient safety.