China NMPA Product Recall - Nautilus ECMO Oxygenator (Disposable Membrane Oxygenator), Nautilus Smart ECMO Module (Disposable Membrane Oxygenator)

Michigan Critical Care Consulting Company MC3 Inc. has initiated a voluntary Class II recall of its single-use membrane oxygenators, specifically the Nautilus ECMO Oxygenator (National Medical Device Registration Certificate 20223100002) and the Nautilus Smart ECMO Module (National Medical Device Registration Certificate 20233100157). This recall, reported by Medtronic (Shanghai) Management Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) on December 20, 2023, addresses a critical issue: limited water flow within the heat exchange tubing of these devices. This defect poses a significant risk by potentially compromising the oxygenators' ability to regulate a patient's body temperature effectively during medical procedures. Operating under the NMPA's regulatory framework for medical devices, MC3 Inc. is undertaking this action to rectify the identified product deficiency and uphold patient safety. Detailed information regarding the affected models, specifications, and batches is available in the accompanying recall event report form.