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.
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 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…
- 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.
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