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

Makvision (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Level II recall on September 15, 2021, for its Intra-Aortic Balloon Pump, branded as CARDIOSAVE. This recall, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, addresses significant performance and safety concerns with the medical device.

The core issues identified involve inaccurate helium meter readings, which are attributed to persistent electromagnetic compatibility interference. This defect could potentially impair the device's functionality and impact patient care. Additionally, the device has been observed to shut down unexpectedly upon battery removal under certain circumstances, raising concerns about operational reliability during critical medical interventions.

Makvision's proactive measure targets specific affected product models, specifications, and batches, with comprehensive details provided in the "Medical Device Recall Event Report Form." This voluntary recall emphasizes the company's dedication to rectifying product deficiencies, adhering to regulatory requirements, and ensuring the safety and well-being of patients utilizing these life-supporting medical devices.