Neurovision Cobra x5 EMG ET Tube Recalled for Insulation Softening
Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (medical device) where the defect could render the device unusable, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Neurovision Medical Products Inc is recalling the Cobra x5 2-Ch EMG ET Tube, 7.0mm (REF: LTE700DCM-5). The recall involves 3,425 units distributed worldwide, including nationwide in the United States and in Canada, the Dominican Republic, and Hong Kong.
The recall was initiated because the electrode insulating material on the tube may soften over time. This softening makes the material more susceptible to damage from scratching or bending. Such damage could stop or inhibit the transmission of the EMG signal from the electrodes to the monitor, rendering the device unusable.
The affected product is used for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature, as well as providing an open airway for patient ventilation during surgical or parasurgical care. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
- Manufacturer
- Neurovision Medical Products Inc
- Affected units
- 3,425
Distribution
Part of a larger recall action
This product is one of 9 recalled by Neurovision Medical Products Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Neurovision Medical Products Inc
See all →- ModerateHummingbird stimulated EMG kit packaging shows the wrong part number
FDA (Devices) · 2025-07-16
- ModerateCobra EMG ET Tube Recalled Due to Incorrect Size Labeling
FDA (Devices) · 2024-09-04
- ModerateNeurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
FDA (Devices) · 2020-09-02
- ModerateNeurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
FDA (Devices) · 2020-09-02
- HighNeurovision Recalls Cobra x5 2-Ch EMG ET Tubes Due to Insulation Defect
FDA (Devices) · 2020-09-02
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateCobra EMG ET Tube Recalled Due to Incorrect Size Labeling
FDA (Devices) · 2024-09-04
- HighMedtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard
FDA (Devices) · 2017-01-04
- SevereMedtronic Recalls NIM TriVantage EMG Endotracheal Tubes Due to Cuff Leakage
FDA (Devices) · 2013-06-12
- HighNIM TriVantage EMG Endotracheal Tubes Recalled for Loss of Nerve Monitoring
FDA (Devices) · 2024-01-17
- SevereNIM EMG Endotracheal Tubes recalled for risk of airway obstruction
FDA (Devices) · 2022-09-07
- HighMedtronic endotracheal tubes recalled due to manufacturing nonconformity
FDA (Devices) · 2022-03-16