Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening
Neurovision is recalling Cobra x5 EMG ET tubes because the insulating material 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 involves a medical device where a defect could render the device unusable during a procedure, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Neurovision Medical Products Inc is recalling the Cobra x5 1-CH EMG ET Tube, 6.0mm (REF: LTE700S-5). The affected lots are 073119A, 082019B, 022820A, 041620C, and 062520A. These devices are 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 was initiated because the electrode insulating material on the tube may soften over time. This softening makes the material more susceptible to damage from scratching or bending. If damaged, the device may stop or inhibit the transmission of the EMG signal 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. Healthcare providers and facilities should stop using the affected lots and contact Neurovision Medical Products Inc for further instructions.
The recalled product
- Product
- Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - 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 ventilation…
- Manufacturer
- Neurovision Medical Products Inc
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 (1)
- Kit Lots: 073119A 082019B 022820A 041620C 062520A
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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