Recall Z-0696-2024 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
| Date | Jan 10, 2024 (initiated Nov 7, 2023) |
| Status | Open, Classified |
| Reason | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/07/2023 via 2-day UPS mailing. The notice explained the problem, the potential health risk, and requested segregation and quarantine pending return of the affected product. For questions, contact: neuro-quality@medtronic.com. |
| Quantity | 80569 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE Medtronic Xomed, Inc., Jun 27, 2012 |