CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled
Neurovision Medical Products is recalling Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET, distributed nationwide in the US. The recall was initiated on 21 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2900-2020
- FDA event ID
- 86102
- Recalling firm
- Neurovision Medical Products, Ventura, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2020
- FDA classified
- 27 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Jul 2020 | Recall initiated by company | |
| 27 Aug 2020 | Classified by FDA | +37 days |
| 2 Sep 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Product as listed by the FDA
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 airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, SC, SD, TN, TX, WA, WI and the countries of Canada, Dominican Republic, Hong Kong.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaMissouriMississippiNebraska
Questions about this recall
Why was it recalled?
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Which lots are affected?
Kit Lots 070919A 072619A, 073119A 082019B, 120219D 120319G 120519A 121819E 121919E 122019B 010820D 011520A 011620A 012320D 012420B 030620A 031220E 052120B 062620A 022820A 041620C 062520A
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, SC, SD, TN, TX, WA, WI and the countries of Canada, Dominican Republic, Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 86102This product is part of a recall event; the main page for the event is Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 1-CH EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 1-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recalled | Neurovision Medical Products | Other | Nationwide | |
| CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
More recalls from Neurovision Medical Products
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stimulated EMG Kit with Hummingbird recalled | Neurovision Medical Products | Packaging Defects | CA |
| Device | CLASS II | Cobra, 3-Plate EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Labeling Errors | Nationwide |
| Device | CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
| Device | CLASS II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recalled | Neurovision Medical Products | Other | Nationwide |
| Device | CLASS II | Cobra x5 2-Ch EMG ET Tube recalled by Neurovision Medical Products | Neurovision Medical Products | Other | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |