N/A 8225101 (UDI 20199150023862)Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225101 5PK PRASS STD PROT HANDLE · Class 2
Data updated Oct 13, 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 20199150023862), received between Jun 4, 2026 and Sep 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
It was reported that intra op, the EMG tube and probe was connected but only one side can be sensed so it had to be disconnected and procedure was delayed 1 hour and it was completed without the use of the device and the cuff and tube was checked prior to use ad it was function properly. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864494 ↗MalfunctionJun 22, 2026False Negative Result
IT WAS REPORTED THAT INTRA-OP, WHEN USING THE NIM STIMULATOR, THEY DIDN'T GET ANY RESPONSE ON THE MONITOR. THEY RECONNECTED EVERYTHING AND RETESTED IT AFTER CONCLUDING THAT THE PROBLEM WAS WITH THE NIM STIMULATOR. THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578682 ↗MalfunctionJun 4, 2026False Negative Result
IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE; PROBE IS UNABLE TO STIMULATE AN EMG RESPONSE WHEN USED. PROCEDURE WAS COMPLETED WITH REPLACEMENT PROBE USING THE SAME CAPITAL EQUIPMENT. REPLACEMENT PROBE IS ABLE TO STIMULATE AN EMG RESPONSE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25390160 ↗
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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