NIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes worldwide for noise, lead-off issues, high impedance, and loss of or intermittent nerve monitoring. The 80,569 affected units may fail to provide reliable nerve monitoring function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. However, loss of nerve monitoring function during use represents a risk-of-harm scenario, placing this in the High severity category per the rubric's criteria for risk-of-harm products where patient injury has not yet been reported.
Plain-English summary
Medtronic Xomed, Inc. is recalling NIM TriVantage EMG Endotracheal Tubes, which include nerve monitoring capability. The recall affects approximately 80,569 units in various sizes, distributed worldwide.
The company received reports from customers of noise from the NIM System, lead-off issues, high impedance readings, and loss of or intermittent nerve monitoring. These malfunctions may prevent the device from functioning reliably.
The affected devices have been distributed worldwide. Patients and healthcare providers who used NIM TriVantage EMG Endotracheal Tubes should be aware of this recall.
Healthcare facilities should identify and isolate affected inventory using the specific model and serial numbers provided by the manufacturer. Patients with questions should contact their healthcare provider.
The recalled product
- Product
- 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
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- nerve-monitoring-loss
- lead-off
- high-impedance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) 8229706
- GTIN 00643169782587
- Serial Numbers: 0225892912
- 0225894523
- 0225904858
- 0226227428
- 0226246448
- 0226246716
- 0226253848
- 0226258673
- 0226276006
- 0226294121
- 0226299303
- 0226299304
- 0226321727
- 0226350207
- 0226604403
- 0226628515
- 0226648757
- 0226684520
Distribution
Distribution scope not specified by the agency.
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