Skip to content

NA MDP201 (UDI 00613994911025)Recalls & reported problems

Medtronic Xomed, Inc. · PROBE MDP201 MUTE DETECTOR · Class 2

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 00613994911025), received between Nov 6, 2018 and Apr 18, 2019 — 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

Patient problems

  • No Known Impact Or Consequence To Patient2
  • 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.

  • MalfunctionApr 18, 2019Use of Device Problem; Use of Device Problem

    ON FOLLOW UP, IT WAS CONFIRMED THAT THE DEVICE STOPPED WORKING PRIOR TO USE AND THERE WAS NO PATIENT OR STAFF IMPACT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8529177 ↗
  • MalfunctionNov 6, 2018Use of Device Problem; Use of Device Problem

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT THE MUTING PROBE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8041097 ↗

Other STIMULATOR, PHOTIC, EVOKED RESPONSE devices

All STIMULATOR, PHOTIC, EVOKED RESPONSE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.