Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic Xomed, Inc. NIM EMG Endotracheal Tube and NIM CONTACT EMG Endotracheal Tube [HKMD number: 140321].
According to the MHRA, the manufacturer has issued a safety notice regarding the use of the NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube since updates to the labeling were granted. The manufacturer has received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube. NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT Reinforced EMG Endotracheal Tube are silicone tubes with the main shaft reinforced by a wire coil to prevent collapse while maintaining flexibility. The cuffs are also silicone. An over-inflated cuff increases intra-cuff pressure which can cause the silicone cuff to extend, herniate, or distort over the end of the tube and/or the murphy-eye causing obstruction and loss of ventilation.
For further information, please visit https://mhra-gov.filecamp.com/s/d/GO6130Jpqfq5M4pP
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Feb 2024