NA 8225275Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225275 BALL TIP 1MM ROHS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490176750), received between Oct 10, 2018 and Aug 17, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem2
- Device Sensing Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2020Use of Device Problem; Use of Device Problem
A HEALTHCARE PROVIDER (HCP) REPORTED THAT WHEN THE DOCTOR USED THE PROBE TO DETECT DURING THYROIDECTOMY NIM DID NOT RESPOND, THE DOCTOR CHECKED THAT THE ELECTRODE CHECK WERE DISPLAYED NORMALLY, AND TRIED TO USE THE PATIENT SIMULATOR TO FIND THAT BOTH THE NIM AND THE PATIENT INTERFACE WERE NORMAL. SO THE DOCTOR THOUGHT THAT THE PROBE WAS DEFECTIVE. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW UP IT WAS DETERMINED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10418189 ↗MalfunctionOct 10, 2018Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A DISTRIBUTOR THAT AFTER INTUBATION DURING A THYROIDECTOMY PROCEDURE, THE PROBE DID NOT FUNCTION PROPERLY. THERE WAS ELECTRIC CURRENT BUT THERE WAS NO RESPONSE. THE DOCTOR CHECKED ALL THE CONNECTIONS BUT WAS NOT ABLE TO RESOLVE THE ISSUE. ANOTHER PROBE WAS USED WHICH FUNCTIONED WELL. THE PROCEDURE WAS COMPLETED BUT DELAYED FOR ABOUT 5 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7953736 ↗
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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