Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
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. The hazard involves the device becoming unusable due to signal loss, which is a functional failure rather than a direct physical injury or contamination risk, fitting the criteria for a moderate severity recall.
Plain-English summary
Neurovision Medical Products Inc. is recalling the Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm (REF: NVTKIT-C7-5). The recall involves 7,250 units distributed worldwide, including the United States, Canada, the Dominican Republic, and Hong Kong.
The recall is due to a defect in the electrode insulating material on the Cobra EMG ET tube. This material may soften over time, making it 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 for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature.
This product is intended for use during surgical or parasurgical care to provide an open airway for patient ventilation. Users should stop using the affected kits and contact Neurovision Medical Products Inc. for further instructions.
The recalled product
- Product
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an…
- Manufacturer
- Neurovision Medical Products Inc
- Affected units
- 7,250
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
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