NA 5140-530-855Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Laryngeal Electrode Select, ID 6-7mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327292206), received between May 29, 2019 and May 30, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Sense3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2019Failure to Sense; Failure to Sense
IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8655719 ↗MalfunctionMay 29, 2019Failure to Sense; Failure to Sense
IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8651763 ↗MalfunctionMay 29, 2019Failure to Sense; Failure to Sense
IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8651693 ↗
Other STIMULATOR, NERVE devices
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- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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