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 Tube, 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-2902-2020
- 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, 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 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: 012320C 012720C 012820B 012920C 013020C 020720D 021020D 021320E 021420B 021420D 021820B 031220A 031620C 041620A 052120C 060820F 061120B 111319C 120219G 120619A 121819B 121919F 122319B 122719A 123019A 072919B 073019A 073119B 010820E 090419A 112619A 101019B 102319B 102819A 102919A 103019A 103119A 111219F 112619G 112719C 120219F 060420A 062920A
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 86102| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube recalled | 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 |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |