MR8 Stealth-Midas EM800N-RRecalls & reported problems
Medtronic Ps Medical, Inc. · MOTOR EM800N-R MR8 ELEC NAVIGATED RFRB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000063337), received between Dec 5, 2024 and Dec 4, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (12 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 Device12
- Corroded2
- Device Displays Incorrect Message1
- Loss of Power1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR EXPERIENCED OVERHEATING DURING AN INTRA-OPERATIVE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23712895 ↗MalfunctionOct 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT PRIOR TO USE, THE MOTOR WAS NOT LOCKING ATTACHMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424523 ↗MalfunctionOct 18, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR EXPERIENCED OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23332843 ↗MalfunctionOct 15, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO USE, THE MOTOR WAS ALLEGED TO HAVE EXPERIENCED OVERHEATING AS A PRE-OPERATIVE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298333 ↗MalfunctionAug 29, 2025Corroded; Corroded
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920318 ↗MalfunctionJul 17, 2025Overheating of Device; Loss of Power; Overheating of Device; Loss of Power
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND LOSS OF POWER. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22534960 ↗MalfunctionJun 22, 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 22304109 ↗MalfunctionJun 12, 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 22196411 ↗MalfunctionMay 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 IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22067873 ↗MalfunctionMar 25, 2025Overheating of Device; Device Displays Incorrect Message; Overheating of Device; Device Displays Incorrect Message
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 21688167 ↗MalfunctionMar 10, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DEVICE WAS OVERHEATING. NO PATIENT IMPACT REPORTED. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559927 ↗MalfunctionMar 7, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DEVICE OVERHEATING. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543796 ↗MalfunctionJan 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. 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 21123367 ↗MalfunctionDec 5, 2024Corroded; Overheating of Device; Corroded; Overheating of Device
IT WAS REPORTED THAT OVERHEATING AND CORROSION. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20851488 ↗
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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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