Midas Rex® Stylus Touch® EM210RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00613994790217), received between Jan 6, 2017 and Jun 9, 2022 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (36 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT PRE-OP, THE DEVICE GOT OVERHEATED. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644544 ↗
• MalfunctionOct 15, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE HEATS UP PRE-OPERATIVELY. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE HEATING OCCURRED ONCE SYSTEM WAS TURNED ON (WITHIN A MINUTE). THE HCP WAS NOT AWARE OF ANY TROUBLESHOOTING DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639210 ↗
• MalfunctionMar 17, 2021Overheating of Device; Vibration; Noise, Audible; Overheating of Device; Vibration; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS RUNNING HOT, BUZZING AND CHATTERING PRIOR TO USE. THE OVERHEATING WAS REPORTED BEFORE ONE MINUTE. ONLY TROUBLESHOOTING THAT WAS DONE WAS TRYING THE LOCKS AND RE-SEATING THE BUR ITSELF. 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 11502723 ↗
• MalfunctionAug 6, 2020Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A HANDPIECE WAS OVERHEATING AND MAKES A GRINDING NOISE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10372472 ↗
• MalfunctionNov 13, 2019Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HAND PIECE GOT HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315706 ↗
• MalfunctionAug 20, 2019Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HAND PIECE WAS HEATING UP. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8909716 ↗
• MalfunctionJun 5, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS GETTING REALLY HOT PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671757 ↗
• MalfunctionMay 31, 2019Overheating of Device; Overheating of Device

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE HANDPIECE OVERHEATED DURING IN-SERVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660127 ↗
• MalfunctionMay 28, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8648200 ↗
• MalfunctionApr 29, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE HANDPIECE OVERHEATED. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8561510 ↗
• MalfunctionFeb 12, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED DURING TESTING. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330646 ↗
• MalfunctionJan 22, 2019Overheating of Device; Overheating of Device

  THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS OVERHEATING DURING TESTING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266666 ↗
• MalfunctionJan 11, 2019Overheating of Device; Overheating of Device

  THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS GETTING TOO HOT WHEN POWERED ON DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8240851 ↗
• MalfunctionNov 21, 2018Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8096892 ↗
• MalfunctionNov 20, 2018Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS FOUND TO BE RUNNING HOT DURING A PREVENTATIVE MAINTENANCE PERFORMED BY THE MANUFACTURER REPRESENTATIVE. A HEALTH CARE PROVIDER HAD ASKED TO PERFORM A PREVENTATIVE MAINTENANCE, BECAUSE THE PHYSICIAN HAD BEEN COMPLAINING ABOUT THE DEVICE BEING HOT WHILE BEING USED DURING SURGERY. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091678 ↗
• MalfunctionNov 20, 2018Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS FOUND TO BE RUNNING HOT DURING A PREVENTATIVE MAINTENANCE PERFORMED BY THE MANUFACTURER REPRESENTATIVE. A HEALTH CARE PROVIDER HAD ASKED TO PERFORM A PREVENTATIVE MAINTENANCE, BECAUSE THE PHYSICIAN HAD BEEN COMPLAINING ABOUT THE DEVICE BEING HOT WHILE BEING USED DURING SURGERY. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091468 ↗
• MalfunctionOct 22, 2018Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HANDPIECE WAS NOT WORKING PROPERLY PRIOR TO THE PROCEDURE. THERE WAS ALSO INFORMATION THAT THE HANDPIECE OVERHEATED DURING IN-SERVICE. IN BOTH CASES THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7990620 ↗
• MalfunctionAug 15, 2018Overheating of Device; Overheating of Device

  CUSTOMER THAT THE EM210 OVERHEATED SIGNIFICANTLY. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787678 ↗
• MalfunctionAug 15, 2018Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THAT THE STYLUS TOUCH HANDPIECE WAS OVERHEATING SIGNIFICANTLY. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784236 ↗
• MalfunctionJun 6, 2018Overheating of Device; Overheating of Device

  CUSRTOMER REPORTED THE EM210 HEATED UP. NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7575216 ↗
• MalfunctionApr 5, 2018Overheating of Device; Overheating of Device

  THE INITIAL REPORT FROM THE CUSTOMER ON (B)(6) 2018 INDICATED THE DEVICE WAS NOT WORKING. NO PATIENT IMPACT REPORTED ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A HAND-PIECE. IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING AND HEATED UP INSTANTANEOUSLY WHEN USED FOR TESTING PURPOSES PRIOR TO DECONTAMINATION. THE HCP NOTED THAT THEY HAD TESTED THE DEVICE PRIOR TO PUTTING IT IN SERVICE AND THAT IT WAS NEVER USED IN THE OPERATING ROOM (OR). THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401589 ↗
• MalfunctionMar 29, 2018Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THAT DURING TESTING THE UNIT WAS OVERHEATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382494 ↗
• MalfunctionMar 22, 2018Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THE DRILL HAND PIECE WAS GETTING HOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363298 ↗
• MalfunctionMar 13, 2018Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THE HANDPIECE WAS GETTING WARM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7334676 ↗
• MalfunctionMar 7, 2018Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  SALES REP. REPORTED THE STYLUS TOUCH HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321555 ↗

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: