Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening
Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional failure (loss of signal) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Neurovision Medical Products Inc. is recalling the Cobra x5 1-Ch EMG ET Tube, 7.0mm (REF LTE700M-5). This medical device 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 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 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 products were distributed worldwide, including nationwide in the United States and in Canada, the Dominican Republic, and Hong Kong. The recall covers specific kit lots listed in the agency's documentation. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - 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…
- Manufacturer
- Neurovision Medical Products Inc
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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