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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Medtronic Xomed Inc NIM Trivantage EMG Endotracheal Tube [Product code: 8229737] [HKMD No.: 140321].
According to TGA, the manufacturer is recalling specific lots of the NIM TriVantage EMG Endotracheal Tubes. This recall was initiated because of reports received in which customers reported experiencing noise from the NIM system, lead-off or high impedance issues, or loss of/intermittent nerve monitoring. The potential hazards can cause unintended extubation, a delay or a cancelation of the procedure as well as dysphonia, dysphagia, dyspnoea, or possible nerve damage.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00956-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Nov 2023