Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.
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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional failure (loss of signal) rather than a direct physical injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Neurovision Medical Products Inc is recalling 1,089 units of the Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm (REF NVTKIT-C6-5). The recall affects specific kit lots 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 susceptible to damage from scratching or bending. Such damage could stop or inhibit the transmission of EMG signals from the electrodes to the monitor, rendering the device unusable for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature.
The source text does not report any illnesses, injuries, or deaths associated with this defect. Healthcare providers and patients should stop using the affected kits and contact Neurovision Medical Products Inc for further instructions or replacement.
The recalled product
- Product
- Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - 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
- 1,089
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Kit Lots 070919A 072619A
- 073119A 082019B
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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