# China NMPA Product Recall - Neurological monitoring endotracheal intubation

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/dff70972-4dcc-4b1e-8a39-e4cfa7102ac1
Source feed: China

> China NMPA product recall for Neurological monitoring endotracheal intubation by Medtronic (Shanghai) Management Co., Ltd. published January 18, 2022. Recall level: Level 2. On January 18, 2022, Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. has initiated a voluntary recall of its neuromonitoring endotracheal tubes.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2022-01-18
- Product Name: Neurological monitoring endotracheal intubation
- Recall Level: Level 2
- Recall Reason: After intubation, it was difficult to immediately check the patient's condition via electrodes on the NIM main unit; during surgery, the connection between the endotracheal tube and the main unit for neuromonitoring was lost; and excessive signal noise was received from the console due to electrode wire detachment. The root cause lies in the adhesive coating step during the manufacturing process.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2