NA 8225825Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225825 3PK INCREMT STD PRASS 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 20885074472915), received between Sep 24, 2018 and May 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Energy” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Deliver Energy1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING OR AFTER USE THE STIMULUS WAS NOT WORKING. THERE WAS INCONVENIENT FOR STAFF; HAD TO OPEN AN ADDITIONAL PROBE. NO APPARENT HARM. THERE WAS NO UNEXPECTED OR PROLONGED CARE AND THE ISSUE OCCURRED FOR THE FIRST TIME. THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14314685 ↗MalfunctionSep 24, 2018Failure to Deliver Energy; Failure to Deliver Energy
A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PROBE WAS NOT DETECTING THE CONTACT ON THE PATIENT DURING THE PROCEDURE. THE DEVICE FAILED TO WORK AS NO AUDIBLE TONE WAS HEARD DURING EXPLORATION. TROUBLESHOOTING WAS DONE BY USING ANOTHER DEVICE AND PROCEEDING WITH THE CASE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7903362 ↗
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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