Midas Rex® AF02Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00721902481857), received between Mar 16, 2017 and Sep 29, 2026 — classified as 3 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (79 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 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Naturally Worn

  It was reported that prior to use, the bearings in the attachment were damaged. There was no patient involved in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927496 ↗
• MalfunctionAug 17, 2026Loss of Power

  It was reported that during intraop the attachment was frozen. 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 50269227 ↗
• MalfunctionJul 5, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT CUT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25712301 ↗
• MalfunctionJul 1, 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 IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679619 ↗
• MalfunctionJul 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT RETAIN THE TOOL. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25675285 ↗
• MalfunctionJun 26, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT BEARING WAS DAMAGED PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632084 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE NOT WORKING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611591 ↗
• MalfunctionJun 24, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE CANNOT LOCK TOOLS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607127 ↗
• MalfunctionJun 24, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT CANNOT LOCK TOOLS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604375 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. 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 25515987 ↗
• MalfunctionJun 16, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF LOCK OR ADJUSTMENT RING STICKING. IT WAS REPORTED THERE WAS NO PATIENT INVOLV EMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514086 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAD BEARINGS DEFECT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513887 ↗
• MalfunctionJun 15, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT CANNOT LOCK THE TOOL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498327 ↗
• MalfunctionJun 15, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS WERE DEFECTIVE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498256 ↗
• MalfunctionJun 12, 2026Naturally Worn

  IT WAS REPORTED THAT THE DURING PRE-OP THE ATTACHMENT HAD BEARING ISSUE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481566 ↗
• MalfunctionJun 11, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF LOSS OF POWER. 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 25466783 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF DETACHMENT OF COMPONENT. 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 25444988 ↗
• MalfunctionJun 9, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE BEARING WAS WORN AND OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438886 ↗
• MalfunctionJun 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE DURING PREOP FOOT PROTECTION WAS ASKEW. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25423821 ↗
• MalfunctionJun 4, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WAS LOCK FAILURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25395199 ↗
• MalfunctionJun 4, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WAS UNABLE TO LOCK PROPERLY WITH THE TOOL ONTO THE HANDPIECE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389100 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PARTS WERE FELL OUT AFTER A USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25353582 ↗
• MalfunctionJun 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DURING INTRAOP IN ATTACHMENT THE BUR COULD NOT BE INSERTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE BROKEN BEARINGS INSIDE THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25353364 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350827 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE OF PARTS FALL OFF. 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 25348435 ↗

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)