Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.
What this means for you
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 hazard involves a functional failure (loss of signal) rather than a direct physical injury or contamination, 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 EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5. The recall affects 1,239 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. The material may soften over time, making it more susceptible to damage from scratching or bending. This 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. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
- Manufacturer
- Neurovision Medical Products Inc
- Affected units
- 1,239
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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