Midas Rex MR8 EM810-RRecalls & reported problems
Medtronic Ps Medical, Inc. · MOTOR EM810-R MR8 ELECTRIC TOUCH REFURB · Class 2
All models of Midas Rex MR8 (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000063344), received between Sep 2, 2024 and Dec 1, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (16 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device16
- Corroded2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Corroded; Corroded
IT WAS REPORTED THAT RUST AND BIOBURDEN WERE FOUND ON THE MOTOR DURING BORESCOPE INSPECTION IN THE STERILE PROCESSING DEPARTMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677700 ↗MalfunctionNov 27, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT MOTOR OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665897 ↗MalfunctionNov 7, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS ALLEGED TO HAVE EXPERIENCED OVERHEATING, WAS RUNNING HOT, AND WAS HEATING UP PRIOR TO USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495758 ↗MalfunctionOct 23, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366607 ↗MalfunctionAug 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 OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22697895 ↗MalfunctionJul 29, 2025Corroded; Corroded
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION. 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 22646492 ↗MalfunctionJul 22, 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 22567152 ↗MalfunctionJul 18, 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 22539770 ↗MalfunctionJun 12, 2025Naturally Worn; Naturally Worn
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF WORN. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192061 ↗MalfunctionMay 30, 2025Overheating of Device; Overheating of Device
ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22112077 ↗MalfunctionMay 26, 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 CONFIRMED WITH THE STAFF(NURSE) THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083886 ↗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. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763325 ↗MalfunctionMar 21, 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 21660948 ↗MalfunctionMar 20, 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 21651079 ↗MalfunctionFeb 24, 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 21444382 ↗MalfunctionNov 21, 2024Overheating 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 A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20743938 ↗MalfunctionNov 6, 2024Overheating 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 RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20621198 ↗MalfunctionSep 2, 2024Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20118373 ↗MalfunctionSep 2, 2024Overheating 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 20117335 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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