Neurovision Medical Products Inc Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or parasurgical care using any compatible nerve monitoring system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - 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.
Brand
Neurovision Medical Products Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Kit Lots: 052219E 052219D 052319A 052919C 053119C 060319A 060619A 060719C 061119A 061419A 061919A 062119A 070119C 071219B 080819B 082719E 091219A 091219B 091319A 091619C 091619D 012920A 020420D 020520B 020620A 020620D 020620G 021020E 021420A 021720D 022020C 022420E 030920C 030920D 031620A 031620B 041620B 051920C 060820E 071719A 071819D 072519A 072519C 080819C 081319A 081919A 082619E 091819B 091919A 091919F 100119A 101019A 101019C 101419D 101719A 110519A 110519B 110519C 110719F 012220A 012220E 012320B 012420D 012820A 012820C 042419A 042519B 042519A 050319A 050619A 050719A 051419C 052119B 082619D 112719G 112719H 120219B 120319B 120619C 051220A 051920A 052620A 052820C 060120C 061120A 061220B
Neurovision Medical Products Inc is recalling Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall Notice, dated July 17, 2020 was sent via email on 7/21/20 and a hard copy via USPS first class mail on 7/28/20-7/29/20 to consignees advising them that Neurovision Medical Products (hereafter NMP) is voluntarily recalling Cobra 1 & 2-Channel EMG Endotracheal Tube, 6 mm, 7 mm, and 8 mm which is used for continuous EMG monitoring and status assessment of the nerves. NMP has initiated this removal due to the potential degradation of the electrode insulation material sooner than the established shelf life. This could make the electrode more susceptible to damage by dental scratching or acute bending. This may interfere with the EMG performance of the device. Failure of the device could result in a delay in the surgical procedure. Malfunction during clinical use should be evident to the clinical user by intermittent or loss of EMG signal and high electrode impedance values. We are aware of one product failure and one complaint associated with the problem. It advises customers to immediately take the following actions: Review the enclosed list of affected lots and product codes. 2. Quarantine product subject to this notice. 3. Cease distribution and use of any product from the affected lots. 4. Advise all applicable departments (including Anesthesia, OR Leadership and Materials Management). 5. Complete and return the enclosed response form as soon as possible: a. Email: customer_service@neurovisionmedical.com b. Fax: (877) 330-1727 6. NMP Customer Service will respond with a return authorization (RMA) number and return shipping label for any stock of affected lots that you may have. 7. If you have distributed this product to another location or entity, notify them of this product recall (include a copy of this notice), and contact NMP Customer Service for a return authorization (RMA). The letter stated the firm is working quickly and closely with their manufacturing team to address the issue. In the meantime, they do have an alt
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026