Midas Rex® EM210 (UDI 00643169360976)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00643169360976), received between Jan 10, 2017 and Mar 30, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (63 reports).

3 other recalls cover devices cleared under the same FDA submission (K081475); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE MOTOR STYLUS TOUCH WAS OVERHEATING, NOTICED IN LESS THAN A MINUTE, AND IRRIGATION WAS USED AND FROZE UP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722356 ↗
• MalfunctionFeb 11, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE STYLUS TOUCH WAS OVERHEATING IN LESS THAN 1 MIN DURING POST-OPERATION/AFTER USE. THEY USED A SPARE DRILL TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358057 ↗
• MalfunctionFeb 23, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT INTRA-OP, THE MOTOR IMMEDIATELY RUNS VERY HOT AND MAKES AN UNCLEAN SOUND. THE ENGINE NO LONGER RUNS AT FULL SPEED. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765153 ↗
• MalfunctionJun 15, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT STYLUS TOUCH HANDPIECE WAS CORRODED AND GETTING VERY HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132465 ↗
• MalfunctionMay 8, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT STYLUS TOUCH MOTOR WAS HEATING UP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884097 ↗
• MalfunctionApr 7, 2023Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE MAKES STRANGE NOISES AND GETS HOT. NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT THE BEGINNING OF PROCEDURE, THE UNUSUAL NOISE WAS HEARD AND THE DEVICE WAS REPLACED IMMEDIATELY WITH ANOTHER ONE. BUT THE INCIDENT WAS REPORTED POST-OPERATIVELY AFTER STANDARD CLEANING PROCEDURE. THE DEVICE WAS USED FOR LESS THAN A MINUTE WHEN THE OVERHEATING WAS NOTICED. AFTER THE PROCEDURE THE MOTOR WAS INSPECTED BY A MEDICAL TECHNOLOGY TECHNICIAN WHO CONFIRMED THE NOISE AND MENTIONED THAT THE DEVICE RAN HOT INSTANTLY, WITHIN ABOUT 10 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16699387 ↗
• MalfunctionMar 3, 2023Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING PRE OP THE STYLUS TOUCH HANDLE WAS GETTING HOT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON FOLLOW UP AS THE PROCEDURE HAS BEEN COMPLETED WITH DIFFERENT UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477027 ↗
• MalfunctionJan 24, 2023Overheating of Device; Overheating of Device

  NEW INFORMATION RECEIVED, OVERHEATING WAS NOTICED BETWEEN ONE AND TWO MINUTES. THE PROCEDURE COMPLETED WITH OTHER DRILL (MR8). THE OVERHEATING OCCURRED BETWEEN ONE AND TWO MINUTES. THE DEVICE WAS BEING RUN AT 1.000RPM AND FORWARDS MODE. FREE HAND IRRIGATION WAS BEING USED AS OUR SYSTEM CANNOT BE COUPLED TO THIS ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 16231721 ↗
• MalfunctionJan 5, 2023Overheating of Device; Mechanics Altered; Overheating of Device; Mechanics Altered

  IT WAS REPORTED THAT THE HANDPIECE IS STATED BY 'USER' TO BE OVER-HEATING AND LOCKING MECHANISM IS STIFF. THERE WAS NO PATIENT INVOL VED AND THERE WAS NO USER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16100654 ↗
• MalfunctionOct 31, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE WAS FOUND TO BE OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703942 ↗
• MalfunctionOct 31, 2022Overheating of Device; Overheating of Device

  HEALTHCARE PROVIDER REPORTED THAT THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15702113 ↗
• MalfunctionOct 28, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT WHEN ON RUN STYLUS STILL ON SAFE MODE, EVEN WHEN SAFE MODE OFF AND RUNS UNINTENTIONALLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690298 ↗
• MalfunctionOct 7, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED AND THERE WAS NO USER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15559202 ↗
• MalfunctionJul 7, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HAD OVERHEATING ISSUE.NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945097 ↗
• MalfunctionMay 25, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED BY HCP THAT THE DEVICE WAS RUNNING HOT. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, DURING THE CASE THE HANDPIECE OVERHEATED, AND THE SURGEON COULD NOT PROCEED UNTIL A NEW HANDPIECE WAS BROUGHT IN. A LAP SPONGE WAS BURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496253 ↗
• MalfunctionJan 5, 2022Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  A HEALTH CARE PROVIDER REPORTED THAT THE MOTOR STOPPED AND DEPENDING ON THE TERMINAL THAT IS USED IT OVERHEATED, THE MILL DIDN'T SPIN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167793 ↗
• MalfunctionOct 19, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE STYLUS HAD HEATING ISSUES. EVENT FOUND PRE-OP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656224 ↗
• MalfunctionOct 18, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE OVERHEATS. THERE WAS NO PATIENT / USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647037 ↗
• MalfunctionSep 23, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE WAS NOT WORKING PROPERLY PRIOR TO USE. THERE IS NO PATIENT IMPACT. ON FOLLOW-UP IT WAS REPORTED THAT DURING TESTING THAT IT WAS GETTING HOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518283 ↗
• MalfunctionAug 25, 2021Overheating of Device; Overheating of Device

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367091 ↗
• MalfunctionAug 17, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE DEVICE OVERHEATED PRE-OP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332545 ↗
• MalfunctionApr 13, 2021Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE HEAT UP AND NOT WORKING. ON FOLLOW-UP, IT WAS REPORTED THAT THE OVERHEATING OCCURRED WITHIN 1 MIN OF USE AND THE MOTOR DID NOT ROTATE DUE TO JAMMED BEARING. THE EVENT OCCURRED PRE-OPERATIVELY. THERE WAS NO TROUBLESHOOTING DONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655319 ↗
• MalfunctionFeb 19, 2021Overheating of Device; Intermittent Loss of Power; Overheating of Device; Intermittent Loss of Power

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE SEEM TO BE EXPERIENCING INTERMITTENT POWER DURING SURGERY AND OVERHEATING. THE PROCEDURE WAS STILL COMPLETED DESPITE THE HANDPIECE SEMI-MALFUNCTIONING. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348392 ↗
• MalfunctionFeb 19, 2021Overheating of Device; Intermittent Loss of Power; Overheating of Device; Intermittent Loss of Power

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE SEEM TO BE EXPERIENCING INTERMITTENT POWER DURING SURGERY AND OVERHEATING. THE PROCEDURE WAS STILL COMPLETED DESPITE THE HANDPIECE SEMI-MALFUNCTIONING. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348126 ↗
• MalfunctionDec 15, 2020Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS GETTING HOT PRE OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11011829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
• Z-0158-2022 · Aug 31, 2021 · Open, Classified
  Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
• Z-2085-2016 · May 13, 2016 · Terminated
  Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: