| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00087-1 |
| Product Name/Description |
NIM Trivantage EMG Endotracheal Tube
Multiple model, material and batch/lot numbers
ARTG 169809
(Medtronic Australasia Pty Ltd - Tube, tracheal, ventilation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/01/2022 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has received complaints associated with potential safety and compliance risks for the NIM Trivantage EMG Endotracheal tubes.
Reported issues include users:
• Experiencing difficulties passing the Electrode Check on the NIM Mainframe immediately after intubating the patient.
• Losing the connection between the EMG Tube and the Mainframe during a procedure, resulting in an “Electrode Off,” “Lead Off,” or “Channel Not Reading” error message on the NIM console screen and the inability to proceed with nerve monitoring.
• Receiving excess signal noise from the NIM console due to lead-off issues.
These issues impact specific production lots that were manufactured between 28-Aug-2019 and 25-Oct-2021.
Medtronic has received 163 complaints worldwide. Of these complaints, there were four (4) cases of aborted procedures and one (1) case of nerve damage. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising customers to not use any of the impacted product. Customer should remove and quarantine all unused impacted product in their inventory. Customers are asked to return all affected product. If an alternative product is needed, a Medtronic representative can assist with identifying a suitable replacement product.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0419 695 557 - Michael Norris, Medtronic |