Midas Rex® EM210 (UDI 00613994633897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994633897), received between Feb 24, 2017 and Jul 28, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Excessive Heating; Excessive Heating

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A HANDPIECE WAS NOT WORKING PROPERLY. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW UP IT WAS REPORTED THAT THE MOTOR OVERHEATED DURING FIRST MINUTE OF SURGERY. ANOTHER DRILL WAS USED. NO PATIENT OR STAFF IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238534 ↗
• MalfunctionJun 15, 2021Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A HANDPIECE HAS EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003740 ↗
• MalfunctionNov 17, 2020Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE OVERHEATED DURING SPINE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10854337 ↗
• MalfunctionMay 11, 2020Overheating of Device; Overheating of Device

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10045871 ↗
• MalfunctionAug 28, 2019Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECE WAS OVERHEATING DURING OPERATION. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939025 ↗
• MalfunctionMar 18, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WARMED UP WHEN IN USE. THE HCP NOTED THAT IT HAPPENED MULTIPLE TIMES AND THE DEVICE WAS USED FOR VETERINARY. THERE WAS NO KNOWN IMPACT.

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

  MAUDE report 8429461 ↗
• MalfunctionMar 7, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE HANDPIECE GOT HOT. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE OVERHEATING WAS SUDDEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8399145 ↗
• MalfunctionSep 8, 2017Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT IT TOOK LESS THAN ONE MINUTE FOR THE DEVICE TO GET HOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6853201 ↗
• MalfunctionJul 14, 2017Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE HANDPIECE OVERHEATED. THE SALES REP REQUESTED THAT THE DEVICES BE RETURNED FOR EVALUATION. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6713702 ↗
• MalfunctionJul 5, 2017Overheating of Device; Overheating of Device

  THE FACILITY REPORTED THE DEVICE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687892 ↗
• MalfunctionFeb 24, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS GETTING WARM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6357004 ↗

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: