MIDAS REX STEALTH MIDAS MR8 EM800NRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000430924), received between Aug 20, 2024 and Sep 4, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Corroded; Corroded

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT 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 22960853 ↗
• MalfunctionAug 13, 2025Corroded; Corroded

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION.IT WAS REPORTED THAT THERE WAS NO PATIENT 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 22793514 ↗
• MalfunctionJun 10, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING L3-L5 POSTERIOR DECOMPRESSION AND FUSION PROCEDURE, DRILL WAS GLOWING, COULD SMELL SMOKE AND VISIBLY SEE SMOKE COMING FROM DRILL. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT DUE TO THE EVENT AND THE PROCEDURE WAS EXTENDED FOR FIVE MINUTES. THE DRILL WAS WRAPPED IN WET LAPS AND REMOVED FROM THE ROOM AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. ADDTIONAL INFORMATION RECEIVED FROM FACILITY STATED THAT THE REPLACEMENT DRILL ALSO EXHIBITING OVERHEATING ISSUES AND REQUIRED MULTIPLE BURRS TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174198 ↗
• MalfunctionJun 10, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING L3-L5 POSTERIOR DECOMPRESSION AND FUSION PROCEDURE, DRILL WAS GLOWING, COULD SMELL SMOKE AND VISIBLY SEE SMOKE COMING FROM DRILL. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT DUE TO THE EVENT AND THE PROCEDURE WAS EXTENDED FOR FIVE MINUTES. THE DRILL WAS WRAPPED IN WET LAPS AND REMOVED FROM THE ROOM AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. ADDTIONAL INFORMATION RECEIVED FROM FACILITY STATED THAT THE REPLACEMENT DRILL ALSO EXHIBITING OVERHEATING ISSUES AND REQUIRED MULTIPLE BURRS TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174175 ↗
• MalfunctionMar 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 OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633535 ↗
• MalfunctionFeb 21, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DEVICE WITH THE REPORT OF OVERHEATING AND SMOKE WHEN USED IN A CASE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435233 ↗
• MalfunctionFeb 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 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 21401432 ↗
• InjuryJan 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING CRANIAL RESECTION PROCEDURE THE EQUIPMENT DOES NOT SHOW THE CORRECT ANATOMICAL POINT. IT WAS REPORTED TH AT BLEEDING OCCURS WHEN USING THE DEVICE. THERE WAS A DELAY OF ONE HOUR OR LONGER AND THE PATIENT WAS UNDER ANASTHESIA DURING THE PROCEDURE. THIS LED TO EXTENDED HOSPITALIZATION FOR THE PATIENT AND THE PATIENT WAS TAKEN INTO THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT IS BEING FOLLOWED UP FROM THE FACILITY.

  Patient problems: Chemical Exposure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21068868 ↗
• MalfunctionDec 29, 2024Overheating 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 DUE REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032163 ↗
• MalfunctionAug 20, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005111 ↗