China NMPA Product Recall - Neurological monitoring endotracheal intubation

On January 18, 2022, Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for specific models and batches of its neuromonitoring endotracheal tubes. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, followed customer complaints regarding product performance. Users reported challenges such as difficulty in immediately checking electrodes on the NIM host after intubation, loss of connection between the endotracheal tube and the host during surgery, and excessive signal noise at the control console attributed to electrode wire detachment. Medtronic's investigation pinpointed the root cause to a deficiency in the adhesive coating step of the manufacturing process. The recall specifically targets products manufactured between August 28, 2019, and October 25, 2021. Detailed information on affected models and batches is available in the 'Medical Device Recall Event Report Form.' The company is undertaking this recall to address the identified product deficiencies and ensure device reliability and patient safety.