NA 8225490Recalls & reported problems
Medtronic Xomed, Inc. · PROBE 8225490 3PK INCREMT 1MM TIP ROHS · Class 2
- 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 20613994430209), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE SITE PHYSICIAN (UNKNOWN) REPORTED A FIBER THAT WAS THOUGHT TO BE A NERVE WAS STIMULATED, BUT THERE WAS NO RESPONSE. NO PATIENT IMPACT OR INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING THE EMG TUBE AND PROBE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7366739 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.