China NMPA Product Recall - Extracorporeal Blood Pumping Console

On March 25, 2022, Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class I recall of its Extracorporeal Blood Pumping Console Centrifugal Pump Control Monitoring System. This recall was reported to the National Medical Products Administration (NMPA) in China. The primary issue identified involves a critical design difference: a spare component possesses a maximum voltage input that differs from the original component. This discrepancy can lead to voltage spikes within the main unit's system controller module, potentially causing failures in the DC-DC converter and D88 diode. Such failures could compromise the functionality and safety of the medical device. The decision to recall was made voluntarily by Medtronic Inc. to address these significant safety concerns. Detailed information regarding specific product models, specifications, and batch numbers affected is available in the "Medical Device Recall Event Report Form" provided by the NMPA. This action underscores the manufacturer's commitment to patient safety and adherence to medical device regulations under the NMPA's oversight.