MIDAS REX® EM210RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00643169945371), received between Nov 20, 2018 and Apr 29, 2024 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (45 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SERVICING STYLUS TOUCH HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199583 ↗
• MalfunctionNov 16, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BURNING THE SAW BLADE WHEN IN USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148223 ↗
• MalfunctionSep 5, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP HANDPIECE WAS OVERHEATING. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682495 ↗
• MalfunctionAug 21, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE STYLUS TOUCH HANDPIECE WAS RUNNING HOT WHEN USED FOR LESS THAN A MINUTE CONTINUOUSLY. THE DEVICE WAS BEING RUN AT 75000 RPM IN ON/OFF MODE NOT VARIABLE. 20ML OF IRRIGATION WAS BEING USED. THE DEVICE WAS REMOVED AND ANOTHER STYLUS TOUCH HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584622 ↗
• MalfunctionAug 7, 2023Overheating of Device; Overheating of Device

  THE EVENT OCCURRED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467836 ↗
• MalfunctionJun 30, 2023Overheating of Device; Overheating of Device

  AS PER PRE-REPAIR TEMPERATURE TEST RESULTS THIS EVENT HAS BEEN DEEMED NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237226 ↗
• MalfunctionFeb 6, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OP, THE MOTOR HAD AN EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT. THEY HAD PLUGGED IT INTO TWO SEPARATE MACHINES AND THEY SAID THE SAFETY WOULDN'T COME OFF, AND THEN IT OVERHEATED AND WOULD NOT WORK. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE, AND IT NEVER ACTUALLY MADE IT INTO USE, AS IT DID NOT WORK AT THE BEGINNING OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302407 ↗
• MalfunctionJan 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE DEVICE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135851 ↗
• MalfunctionJan 6, 2023Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING PRE-OP, THE STYLUS TOUCH HAD EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110547 ↗
• MalfunctionAug 30, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OP THE DEVICE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317696 ↗
• MalfunctionAug 11, 2022Overheating of Device; Overheating of Device

  HEALTH CARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE THAT PRE-OP, THE DEVICE WAS HOT. NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213015 ↗
• MalfunctionJul 13, 2022Break; Vibration; Break; Vibration

  IT WAS REPORTED THAT THE TIP WAS UNSECURED AND BOUNCES WHEN IN USE. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003411 ↗
• MalfunctionJul 6, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE HEATS UP. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935573 ↗
• MalfunctionMay 31, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE GETS HOT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549449 ↗
• MalfunctionApr 25, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED BY HCP THAT DURING PRE-OP, DEVICE IS GETTING HOT/SMOKING. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193038 ↗
• MalfunctionJan 5, 2022Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT THE DEVICE HAD OVERHEATING /SHAKING POST-OPERATIVE . NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169168 ↗
• MalfunctionNov 30, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE IS OVERHEATING DURING PRE-OP. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891306 ↗
• MalfunctionNov 23, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEAT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859873 ↗
• MalfunctionSep 1, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEATED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406797 ↗
• MalfunctionAug 25, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS NOT WORKING PROPERLY. ON FOLLOW-UP, IT WAS REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE MOTOR HEATED UP WITHIN A MINUTE PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT. TROUBLESHOOTING DONE INCLUDED CHANGING THE ATTACHMENTS AND ADJUSTING BEARING BUT IT WAS STILL HEATING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364871 ↗
• MalfunctionAug 20, 2021Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE WAS MAKING GRINDING NOISE AND GOT VERY HOT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348840 ↗
• MalfunctionAug 19, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED WITHIN 1 MINUTE OF USE DURING THE PROCEDURE. 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 12342587 ↗
• MalfunctionJul 23, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT OR STAFF IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT CHATTER OR VIBRATION WAS NOTED ON THE DEVICE DURING THE PROCEDURE WHILE BEING USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216818 ↗
• MalfunctionJul 23, 2021Excessive Heating; Excessive Heating

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP IT WAS REPORTED THAT THE DEVICE HAD HEATING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216798 ↗
• MalfunctionJun 29, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083857 ↗

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: