Neurovision Recalls Cobra x5 2-Ch EMG ET Tubes Due to Insulation Defect
Neurovision Medical Products Inc is recalling 1,058 Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften, potentially stopping EMG signal transmission.
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: The recall involves a risk-of-harm product where the device may become unusable, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Neurovision Medical Products Inc is recalling 1,058 units of the Cobra x5 2-Ch EMG ET Tube, 8.0mm (REF: LTE700DCL-5). The affected devices are 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 recall is due to a defect in the electrode insulating material, which may soften over time. This softening makes the material more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
The affected units were distributed worldwide, including nationwide in the United States and in Canada, the Dominican Republic, and Hong Kong. Specific lot numbers are listed in the agency's recall record. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - 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 during
- Manufacturer
- Neurovision Medical Products Inc
- Affected units
- 1,058
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 Cobra EMG ET Tube Recalled for Insulating Material Softening
FDA (Devices) · 2020-09-02
- 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
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12