Database updated: 18 November 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28825 |
| Brand Name: | ENT - NIM EMG Endotracheal Tubes |
| Model: | Multiple serial numbers |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Xomed |
| Issue: | The manufacturer has received complaint reports from customers experiencing issues with the Trivantage EMG Tubes during use. Reported issues include users: Experiencing difficulty 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 13/1/2022 |
