Midas Rex® AA10 (UDI 00643169741027)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169741027), received between Jul 7, 2020 and Aug 17, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the attachment with the report of difficulty with assembly. It was reported 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 50269704 ↗
• MalfunctionAug 14, 2026Difficult to Insert

  It was reported that the attachment cannot properly lock cutter tool 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 50248674 ↗
• MalfunctionJul 29, 2026Difficult to Insert

  It was reported that the blade is blocking and not handling. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064845 ↗
• MalfunctionJul 5, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25712775 ↗
• MalfunctionJun 27, 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 BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25645034 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. 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 25556842 ↗
• MalfunctionJun 15, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE, TOOL CANNOT INSERT IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501011 ↗
• MalfunctionJun 12, 2026Difficult to Remove

  IT WAS REPORTED THAT THE ATTACHMENT HAS A TOOL LOCKING ISSUE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484779 ↗
• MalfunctionJun 5, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. 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 25418285 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, SMALL BEADS FELL OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328101 ↗
• MalfunctionJul 1, 2025Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375109 ↗
• MalfunctionMar 21, 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. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661072 ↗
• 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 21545145 ↗
• MalfunctionFeb 19, 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 21414791 ↗
• MalfunctionFeb 19, 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 21409374 ↗
• MalfunctionFeb 19, 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. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407492 ↗
• MalfunctionFeb 18, 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 21400433 ↗
• MalfunctionSep 13, 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 INSERTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211247 ↗
• MalfunctionSep 12, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. 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 20199965 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154650 ↗
• MalfunctionAug 21, 2024Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT DUE TO EVALUATION FINDINGS OF OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011102 ↗
• MalfunctionJun 30, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF HEATING UP. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237303 ↗
• MalfunctionSep 29, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY DATE OF EVENT NOTIFICATION:(B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507383 ↗
• MalfunctionJun 1, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. NOTIFICATION DATE IS (B)(6) 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567488 ↗
• InjuryOct 9, 2021Difficult to Insert; Difficult to Insert

  ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602219 ↗

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)