No image published for this recall
Nim trivantage emg endotracheal tube
Official notice
4 Jan 2022
Last checked
4 Jan 2022
An official Health Canada notice concerns Nim trivantage emg endotracheal tube. Reports from the field indicated that customers were experiencing problems with the Trivantage EMG tubes such as having difficulty passing the electrode check screen on the NIM mainframe immediately after intubating the patient, losing the connection between the EMG tube and the mainframe during a procedure resulting in them getting an "electrode off" or "channel not reading message" on the monitor and being unable to proceed with nerve monitoring, or getting excess noise from the tube that would sometimes also result in "lead-off" issues. Between 01-November-2019 and 31-October-2021, a total of 163 product events, some with more than 1 device complaint, were reported related to "lead off /connection/not reading/noisy" issues for the NIM Trivantage Endotracheal Tubes. Of the 180 devices affected within these 163 complaints, a total of 70 devices led to patient impact: -65 devices led to unanticipated extubation during the procedure to resolve the issue, severity of 1 (negligible) -110 cases had no impact reported, with a severity of 1 (negligible) -4 cases were aborted before the procedure could be completed, the severity of 3 (major) -1 device led to nerve damage, which is severity of 4 (critical). -Minor delays in the procedure were also reported for some of these events, none reported impact or injury due to the delay. Product testing has determined that the root cause of the "lead-off" issue is the inconsistencies of the Loctite and Dymax Adhesives that are applied to the tube. The Loctite is applied to hold the Electrodes in the cCampshell on the device to secure the wire harness and connect to the conductive silver ink, and the Dymax is applied along the length of the silver electrode ink traces to provide adherence and insulation. This issue impacts specific production lots manufactured between 28-August-2019 and 25-October-2021. Corrective actions have been implemented to address the underlying issue and new products will not be impacted by this issue. Recall start date: December 23rd , 2021. Published 2022-01-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63791
Official notice
2022-01-04
The hazard
The hazard
Reports from the field indicated that customers were experiencing problems with the Trivantage EMG tubes such as having difficulty passing the electrode check screen on the NIM mainframe immediately after intubating the patient, losing the connection between the EMG tube and the mainframe during a procedure resulting in them getting an "electrode off" or "channel not reading message" on the monitor and being unable to proceed with nerve monitoring, or getting excess noise from the tube that would sometimes also result in "lead-off" issues. Between 01-November-2019 and 31-October-2021, a total of 163 product events, some with more than 1 device complaint, were reported related to "lead off /connection/not reading/noisy" issues for the NIM Trivantage Endotracheal Tubes. Of the 180 devices affected within these 163 complaints, a total of 70 devices led to patient impact: -65 devices led to unanticipated extubation during the procedure to resolve the issue, severity of 1 (negligible) -110 cases had no impact reported, with a severity of 1 (negligible) -4 cases were aborted before the procedure could be completed, the severity of 3 (major) -1 device led to nerve damage, which is severity of 4 (critical). -Minor delays in the procedure were also reported for some of these events, none reported impact or injury due to the delay. Product testing has determined that the root cause of the "lead-off" issue is the inconsistencies of the Loctite and Dymax Adhesives that are applied to the tube. The Loctite is applied to hold the Electrodes in the cCampshell on the device to secure the wire harness and connect to the conductive silver ink, and the Dymax is applied along the length of the silver electrode ink traces to provide adherence and insulation. This issue impacts specific production lots manufactured between 28-August-2019 and 25-October-2021. Corrective actions have been implemented to address the underlying issue and new products will not be impacted by this issue. Recall start date: December 23rd , 2021.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
Checked manually this time?
The app alerts you when a new official recall is published — no searching, no checking back.
Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Product 8
Product 9
Product 10
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic Xomed, Nim Trivantage Emg Endotracheal Tube.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
View full official noticeWeekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 4 Jan 2022. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
