Z-0798-2010

2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical...

Name: Z-0798-2010 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical...
Creator: Neurovision Medical Products Inc
Published: 2010-01-11
License: https://open.fda.gov/license/

Neurovision Medical Products Inc / initiated 2010-01-11 / Terminated

FDA source

Neurovision Medical Products Inc began a recall of 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve on 2010-01-11. The reason FDA records is "This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0798-2010
Status: Terminated
Initiated: 2010-01-11
Posted: 2010-02-22
Terminated: 2011-04-21
Recalling firm: Neurovision Medical Products Inc
Product: 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve.
Product code: ETN Stimulator, Nerve
Reason for recall: This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has c
FDA root cause: Other
Action: URGENT RECALL: Medical Device Letter dated 1/7/10. The letter identified the affected product and provided a list of necessary actions for customers to take. The customers should immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify their customers and notify them at once of this product recall. Their notification to their customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any failure to monitor. Please complete and return the enclosed response form as soon as possible. If you have any questions, call Ryan Rea or Kevin Rea, at 866-815-6999.
Quantity in commerce: 4143
Distribution: Nationwide: CA CO FL GA IL LA MI ND NY OH PA TX UT WA WI)
Product codes and lots: Lot numbers 113008, 054409, 096709

Product code ETN

K003745Class IILaryngeal Surface Electrode-Endotracheal Tube, M-500-Et, Lse-EtRln Systems, Inc. / cleared 2001-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)