Midas Rex MR8 EM800NRecalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR EM800N MR8 ELECTRIC NAVIGATED S8 · Class 2
All models of MIDAS REX MR8 (137)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169912151), received between Nov 9, 2020 and Nov 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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 Device4
- Corroded1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Corroded; Corroded
IT WAS REPORTED THAT THE MOTOR WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED OVERHEATING WERE FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591699 ↗MalfunctionJun 17, 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 22221908 ↗MalfunctionJan 31, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT HANDPIECE IS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21280602 ↗MalfunctionSep 21, 2024Overheating of Device; Material Integrity Problem; Overheating of Device; Material Integrity Problem
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CABLE DAMAGED AND OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20275011 ↗MalfunctionNov 9, 2020Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event
REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT, OR STAFF IMPACT. UPON ANALYSIS, IT WAS NOTED THAT THE DEVICE OVERHEATED ABOVE THRESHOLD. ON FOLLOW UP, IT WAS REPORTED THAT NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10813266 ↗
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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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