Midas RexRecalls & reported problems across all models
Medtronic Xomed, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of Midas Rex by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2017 and Apr 30, 2026 — classified as 148 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (142 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Midas Rex recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 23, 2021Class IIITerminated
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Z-1564-2021 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Midas Rex problems
Device problems
- Overheating of Device142
- Vibration6
- Noise, Audible5
- Mechanical Jam3
- Excessive Heating2
- Intermittent Loss of Power2
- Use of Device Problem2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- No Consequences Or Impact To Patient67
- No Known Impact Or Consequence To Patient5
- No Patient Involvement3
- Superficial (First Degree) Burn1
Midas Rex models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Midas Rex® EM210DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)64 reports
- Midas Rex® EC300RFDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 recall1 report
- MIDAS REX® EM210RFDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)48 reports
- MIDAS REX® EM210DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)24 reports
- Midas Rex® EM210DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)11 reports
Recent Midas Rex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Overheating of Device
IT WAS REPORTED THAT PRIOR TO USE, HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE GOT HEATED WITHIN A MINUTE AND WAS MOVING FORWARD MODE. IRRIGATION WAS USED AND FLOW RATE WAS 30CC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049077 ↗MalfunctionApr 13, 2026Overheating of Device
ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEVICE WAS RUNNING LESS THAN A MINUTE IN FORWARD MODE AT 30CC FLOW RATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854154 ↗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 ↗MalfunctionMar 25, 2026Overheating of Device; Use of Device Problem; Mechanical Jam
THE PRE-REPAIR TEMPERATURE TEST RESULTS OF THE HANDPIECE WERE 97°F AT T1 AND 94°F AT T2 WHEN OPERATED FOR 5 MINUTES AT 60K RPM, WHICH ARE WITHIN THE SPECIFIED LIMIT OF 118.4°F AND MAKING THE EVENT IS CONSIDERED NOT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684158 ↗MalfunctionJan 29, 2026Overheating of Device
IT WAS REPORTED THAT PRE-OP, THE STYLUS TOUCH MOTOR WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211435 ↗MalfunctionAug 1, 2025Overheating of Device; Overheating of Device
AS PER THE PRODUCT ANALYSIS OF THE STYLUS TOUCH HANDPIECE, THE PRE-REPAIR TEMPERATURES ARE WITHIN SPECIFICATION (LESS THAN 118F) AFTER 1 MINUTE, HENCE THE EVENT IS NOT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685788 ↗MalfunctionApr 1, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INTRA-OP, THE STYLUS TOUCH HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21737323 ↗MalfunctionMar 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT DURING SACROILIAC AND THORACOLUMBAR PROCEDURE, THE IPC SYSTEM SHOCKED THE SURGEON TWICE WHEN TOUCHED THE BONE; TRIED MULTIPLE HANDPIECES. THE DRILL WAS THE ONLY DEVICE BEING USE AT THE TIME. AS THE BURR WAS TOUCHING THE BONE, THE USER STEPPED ON THE PEDAL AND WAS SHOCKED. THERE WAS NOT ANY HARDWARE IN THE PATIENT AT THE TIME. SWITCHED OUT THE CONSOLE AND EVERYTHING WAS OK. NO FURTHER SHOCKING. THE SURGEON IS OK, HAD SOME NUMBNESS AND TINGLING FOR APPROXIMATELY 10 MINUTES. THERE WAS A PROCEDURAL DELAY OF LESS THAN AN HOUR AND NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21545230 ↗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 ↗MalfunctionSep 30, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE STYULUS TOUCH WAS OVERHEATING. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20330756 ↗MalfunctionMay 14, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD OVERHEATING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19307447 ↗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 ↗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 ↗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 ↗
Other Medtronic Xomed, Inc. products
All Medtronic Xomed, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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