Neurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect
Neurovision is recalling Cobra x5 EMG endotracheal tubes because the electrode insulation may soften and damage, 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (medical device) where the failure mode (loss of signal) could impact patient care, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Neurovision Medical Products Inc is recalling 1,005 units of the Cobra x5 2-Ch EMG ET Tube, 6.0mm (REF: LTE700DCS-5). The recall covers specific kit lots distributed worldwide, including across the United States, Canada, the Dominican Republic, and Hong Kong.
The recall was initiated because the electrode insulating material on the device may soften over time. This softening makes the insulation more susceptible to damage from scratching or bending. If damaged, the device may stop or inhibit the transmission of EMG signals to the monitor, rendering the device unusable for its intended purpose of continuous EMG monitoring and airway management.
Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Neurovision Medical Products Inc for instructions on return or replacement. The affected lots are: 022119A, 050219A, 051419A, 060519A, 062119B, 081919B, 082019C, 082619B, 082719C, 061720B, 061720D, and 120919D.
The recalled product
- Product
- Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - 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
- Affected units
- 1,005
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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