MIDAS REX LEGEND AF02Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00763000440381), received between Jan 3, 2024 and Sep 16, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (18 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50786582 ↗
• MalfunctionJul 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DRILL GOT STUCK IN THE CRANIOTOME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713675 ↗
• MalfunctionJul 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DRILL GOT STUCK IN THE CRANIOTOME. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713609 ↗
• MalfunctionJun 26, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, BEARING DAMAGE WAS OBSERVED WITH THE PRODUCT. THERE WAS NO PATIENT INOVLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636615 ↗
• MalfunctionJun 23, 2026Naturally Worn

  IT WAS REPORTED THAT, PRIOR TO USE THE ATTACHMENT HAD INTERNAL BEARING BROKEN. 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 25590081 ↗
• MalfunctionJun 18, 2026Overheating of Device

  IT WAS REPORTED THAT A HEATING ISSUE WAS OBSERVED WITH THE DEVICE DURING PRE-OPERATIVE PREPARATION FOR 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 25542934 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE THE ATTACHMENT HAS BEARING DAMAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530499 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRIOR TO USE ATTACHMENT HAD A BEARING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530253 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT DURING MAINTENANCE OF THE ATTACHMENT, A BEARING DEFECT WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467862 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. 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 25466202 ↗
• MalfunctionJun 9, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE USE THE ATTACHMENT HAD A BEARING ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443512 ↗
• MalfunctionJun 5, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS BEARING DAMAGE. AT THE TIME OF EVENT, THERE IS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED THAT BEARINGS WERE DETACHED DURING THE EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404081 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING DEMO IN THE ATTACHMENT PARTS FALL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330711 ↗
• MalfunctionMay 29, 2026Loss of Power; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING DAMAGE AND UNABLE TO RUN PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT FRACTURE OF BEARING FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329116 ↗
• MalfunctionMay 29, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328119 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, BEARING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298109 ↗
• MalfunctionMay 27, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING PROBLEM PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE BROKEN FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297177 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT FOR THE DEVICE HAD BEARING DETACHMENT AND DETACHMENT OF COMPONENTS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273708 ↗
• MalfunctionMay 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FRONT OF THE MILLING CUTTER IS BROKEN . AT THE TIME OF REPORT THERE WAS NO PATIENT INVOLVEMENT/IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073089 ↗
• 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 25063053 ↗
• MalfunctionApr 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD A DISSATISFACTION WITH THE ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24995735 ↗
• MalfunctionApr 23, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DID NOT CLAMP THE CUTTING BLADES. THERE WAS NO PATIENT IMPACT AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975158 ↗
• MalfunctionApr 6, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE THE BEARINGS WERE DAMAGED . AT THE TIME OF REPORT NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE WAS TOOL CAN NOT BE INSERTED IN THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787246 ↗
• MalfunctionApr 3, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE EXHIBITED BROKEN BEARINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777667 ↗
• MalfunctionMar 31, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS BROKEN. IT WAS REPORTED THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATED THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740438 ↗

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)