| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00956-1 |
| Product Name/Description |
NIM TRIVANTAGE EMG Endotracheal tube
Product code: 8229737
ARTG 169809
(Medtronic Australasia Pty Ltd - Tube tracheal ventilation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should:
•Identify, segregate, and quarantine affected products within their inventory. The list of affected lot numbers is included in the customer letter.
Affected product should be returned to Medtronic. Instructions on how to return any impacted products to Medtronic can be found on the Customer. Confirmation Form.
This action has been closed out on 22/4/2024. |
| Contact Information |
+61 0419 695 557 - Michael Norris |