NA MDP201 (UDI 00643169378490)Recalls & reported problems
Medtronic Xomed, Inc. · PROBE MDP201 MUTE DETECTOR ROHS · Class 2
Data updated Oct 16, 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 00643169378490), received between May 21, 2019 and Jan 23, 2026 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRE-OP, THE PROBE WAS NOT COMMUNICATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24158517 ↗MalfunctionAug 6, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DEVICE IS NOT WORKING PROPERLY. THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922217 ↗MalfunctionMay 21, 2019Use of Device Problem; Use of Device Problem
ON FOLLOW-UP, IT WAS REPORTED THAT THE MUTE DETECTOR PROBE WAS UNSTABLE DURING SET UP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8630133 ↗
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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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