Midas Rex EM200-R (UDI 00763000182045)Recalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR EM200-R LEGEND EHS STYLUS ROHS RFB · Class 2
Quick summary
This Medtronic Midas Rex EM200-R Legend is an electric surgical motor used to drive drills during surgery. Its 60 reports almost all describe the handpiece or motor overheating during use, with a few mentioning a burn or perforation; most reports say nothing happened to the patient. There are 2 injuries, no deaths, and 58 malfunction reports. No recalls name this device. Reports fell sharply in the past 12 months, from 54 to 0.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00763000182045), received between Apr 9, 2020 and May 19, 2025 — classified as 2 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (59 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device59
- No Apparent Adverse Event2
- Device Displays Incorrect Message1
- Device Remains Activated1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Burn(s)1
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043306 ↗MalfunctionApr 22, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879752 ↗MalfunctionApr 3, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763358 ↗MalfunctionApr 2, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21754236 ↗MalfunctionApr 2, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750408 ↗MalfunctionMar 26, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21704447 ↗MalfunctionMar 26, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696140 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688144 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685637 ↗MalfunctionMar 20, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21650448 ↗MalfunctionMar 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631449 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21594147 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593063 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21592041 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591055 ↗MalfunctionMar 11, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573776 ↗MalfunctionMar 11, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571268 ↗MalfunctionMar 11, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571174 ↗MalfunctionMar 11, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570255 ↗MalfunctionMar 10, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557689 ↗MalfunctionMar 10, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557598 ↗MalfunctionMar 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551713 ↗MalfunctionMar 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST WAS INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545795 ↗MalfunctionMar 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21544048 ↗MalfunctionMar 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543759 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.