MIDAS REX LEGEND EM100-ARecalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR EM100-A LEGEND EHS · Class 2
All models of MIDAS REX LEGEND (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic Midas Rex Legend EM100-A, an electric surgical motor used to power drilling and cutting during operations. Most of the 31 reports describe the motor overheating, sometimes before a procedure even begins, and a few mention it being hard to remove or coming apart; none involved a patient. Reports dropped sharply, from 20 in the earlier 12 months to 1 in the most recent. No deaths, injuries, or recalls name this device.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00763000430887), received between Mar 28, 2024 and Nov 6, 2025 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (30 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
- Overheating of Device30
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, PRIOR TO USE AND DURING PREPARATION FOR A PROCEDURE, A MOTOR EXHIBITED HEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484059 ↗MalfunctionJun 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 INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201347 ↗MalfunctionMay 6, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971334 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690268 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689883 ↗MalfunctionMar 25, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686263 ↗MalfunctionMar 20, 2025Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND REMOVAL DIFFICULTY. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650235 ↗MalfunctionMar 19, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642221 ↗MalfunctionMar 14, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602864 ↗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 IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572843 ↗MalfunctionMar 10, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559198 ↗MalfunctionMar 4, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515669 ↗MalfunctionMar 4, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512280 ↗MalfunctionMar 3, 2025Overheating of Device; Overheating of Device
A REPAIR REQUEST WAS INITIATED FOR THE DEVICE WITH THE REPORT OF THE DEVICE OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT I NVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502117 ↗MalfunctionFeb 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 INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21455550 ↗MalfunctionFeb 24, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442987 ↗MalfunctionFeb 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 IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355211 ↗MalfunctionFeb 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 INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21345907 ↗MalfunctionFeb 10, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN AND RETURN ON LESS THAN 90 DAYS FROM PURCHASE OR REPAIR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342128 ↗MalfunctionFeb 7, 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 INVOLVEMENT. THE REPAIR REQUEST WAS ESCALATED TO A PRODUCT EVENT DUE TO THE RETURN OF THE PART IN LESS THAN 90 DAYS FROM THE PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330201 ↗MalfunctionFeb 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329989 ↗MalfunctionOct 25, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT HANDPIECE OF THE DEVICE WAS OVERHEATED WHILE THE DOCTOR WAS PERFORMING SURGERY ON THE PATIENT. IT WAS REPORTED THAT THERE WAS DELAY IN PATIENT TREATMENT. IT WAS ALSO REPORTED THAT THE DOCTOR STOPPED USING THE DEVICE IMMEDIATELY AND REPLACED IT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531195 ↗MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521011 ↗MalfunctionOct 24, 2024Overheating of Device; Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20520633 ↗MalfunctionOct 18, 2024Overheating of Device; Overheating of Device
A REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE REPAIR REQUEST WAS ESCALATED TO A PRODUCT EVENT DUE TO THE RETURN OF THE PART IN LESS THAN 90 DAYS FROM THE PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480806 ↗
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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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