Midas Rex® AF03Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00721902481864), received between May 27, 2020 and Jul 3, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Loss of Power

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE DEVICE STOPS RUNNING WHEN IT TOUCHES BONE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700656 ↗
• MalfunctionJun 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BEARING FALLS OFF. IT REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591515 ↗
• MalfunctionJun 9, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446314 ↗
• MalfunctionMay 28, 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 INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313164 ↗
• MalfunctionApr 27, 2026Naturally Worn

  IT WAS REPORTED PRIOR TO USE THAT, THE ATTACHMENT'S BEARING WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATED THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997248 ↗
• MalfunctionApr 21, 2026Naturally Worn

  IT WAS REPORTED THAT THE INTERNAL BEARINGS WERE BROKEN. THERE IS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936404 ↗
• MalfunctionFeb 19, 2025Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL GOT STUCK AND ATTACHMENT GETTING HEATED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414713 ↗
• MalfunctionSep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. 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 20190643 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOISE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030050 ↗
• MalfunctionDec 22, 2023Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO OUT OF BOX FAILURE AND ON EVALUATION DUE BROKEN FOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381038 ↗
• MalfunctionAug 26, 2021Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE, THE DRILL BIT TIP BROKE OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT DID NOT GO INSIDE THE PATIENT, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. UPON EVALUATION, IT WAS NOTED THAT THE FOOT OF THE ATTACHMENT WAS BROKEN. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE TOOL DETAILS AND IT WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375211 ↗
• MalfunctionMar 16, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PARTS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. UPON ANALYSIS, IT WAS NOTED THAT THE LEG AND FOOT WAS DETACHED. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A PROCEDURE DELAY AND AN ADDITIONAL INTERVENTION OF PREPARING A BACKUP DEVICE. IT WAS ALSO REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT POST SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498046 ↗
• MalfunctionMay 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PARTS/FOOT WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10094562 ↗

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)