N/A 8225825 (UDI 20763000041377)Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225825 3PK INCREMT STD PRASS ROHS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000041377), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2022Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE STIMULATOR PROBE DID NOT PROVIDE ANY AUDIBLE RESPONSE AND NO STIMULATION RESPONSE DURING RIGHT THYROIDECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP DEVICE AND DELAY OF 15 MINUTES DURING TROUBLESHOOTING. NO PATIENT IMPACT. ADDITIONAL INFORMATION ON FOLLOW UP, NO INFECTIOUS DISEASES WERE REPORTED WITH THIS PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14361482 ↗
Other STIMULATOR, NERVE devices
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- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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