MIDAS REX LEGEND AA10Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00763000440220), received between Aug 21, 2024 and Jun 19, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (12 reports).

9 other recalls cover devices cleared under the same FDA submission (K020069); 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WAS FOUND DURING EVALUATION..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557162 ↗
• MalfunctionJun 15, 2026Difficult to Insert

  IT WAS REPORTED THAT DEVICE IS NOT HOLDING THE BURR PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498500 ↗
• MalfunctionJun 1, 2026Difficult to Insert; Vibration; Noise, Audible

  IT WAS REPORTED THAT DEVICE, NOISY, VIBRATES, AND IS DIFFICULT TO LOCK. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25346196 ↗
• MalfunctionMay 29, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING USE THE ATTACHMENT CAN'T LOCK THE BUR. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334564 ↗
• MalfunctionMay 21, 2026Difficult to Remove

  IT WAS REPORTED THAT THE ATTACHMENT FAILS TO RETAIN THE BURR PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DISTAL BEARING WAS DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239360 ↗
• MalfunctionMay 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE FROM ONE OF THE ATTACHMENTS THE BALL BEARING HAS FALLEN OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25063104 ↗
• MalfunctionApr 3, 2026Difficult to Insert; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING, SOUND ROUGH, CANNOT HOLD BURR AND LOCKING MECHANISM FAULTY AFTER THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777018 ↗
• MalfunctionMar 25, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT CANNOT BE INSERTED - DETECTABLE BLOCKAGE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684797 ↗
• MalfunctionJan 21, 2026Loss of Power

  IT WAS REPORTED THAT ATTACHMENT HAS BEEN FROZEN. IT WAS REPORTED THAT THERE WAS NO KNOWN PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS IN TUBE WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24130506 ↗
• MalfunctionNov 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT OVERHEATED WHEN ATTACHED TO THE MICROMOTOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542738 ↗
• MalfunctionNov 10, 2025Overheating of Device; Loss of Power; Overheating of Device; Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT IS OVERHEATING AND SEIZED. AT THE TIME OF REPORT, NO KNOWN PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507957 ↗
• MalfunctionAug 12, 2025Difficult to Insert; Difficult to Insert

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780380 ↗
• MalfunctionMay 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF NOT WORKING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO BEARING DETACHMENT. ON FOLLOW, IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103102 ↗
• MalfunctionMar 19, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT HAS A BEARING PROBLEM. WHEN YOU PUT IT INTO OPERATION, THE HANDPIECE OVERHEATS. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639517 ↗
• MalfunctionMar 17, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND SEIZED/NOT RUNNING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616981 ↗
• MalfunctionMar 14, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602945 ↗
• MalfunctionMar 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549336 ↗
• MalfunctionMar 6, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534676 ↗
• MalfunctionOct 7, 2024Loss of Power; Loss of Power

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOSS OF POWER. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384123 ↗
• MalfunctionOct 4, 2024Difficult to Insert; Difficult to Insert

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOCKING MECHANISM DEFECTIVE. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370935 ↗
• MalfunctionSep 26, 2024Loss of Power; Loss of Power

  IT WAS REPORTED THAT THE DEVICE BROKEN AND THAT IT DOESN'T WORK. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313492 ↗
• MalfunctionSep 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT IT IS NOT POSSIBLE TO ROTATE AND SEIZED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300056 ↗
• MalfunctionSep 24, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DOES NOT WORK. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292448 ↗
• MalfunctionSep 24, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF BEARING INSIDE THE TUBE WAS DAMAGED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20288890 ↗
• MalfunctionSep 17, 2024Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND SEIZED/NOT RUNNING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020069. One submission often covers many models, so check the product and lot details in each record.

• Z-1602-2016 · Apr 8, 2016 · Terminated
  Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
• Z-0321-2016 · Oct 21, 2015 · Terminated
  Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
• Z-0546-2010 · Nov 30, 2009 · Terminated
  Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotom
• Z-2156-2008 · May 30, 2008 · Terminated
  Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General S
• Z-1574-05 · Sep 1, 2005 · Terminated
  Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, S
• Z-1067-05 · Jun 29, 2005 · Terminated
  Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137
• Z-0278-05 · Nov 11, 2004 · Terminated
  Medtronic Midas Rex Legend High Speed Pneumatic System
• Z-0213-05 · Nov 3, 2004 · Terminated
  Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
• Z-0419-03 · Nov 11, 2002 · Terminated
  Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)