Midas Rex® AF02R (UDI 00613994469168)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00613994469168), received between Mar 14, 2018 and Jul 2, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (22 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687990 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 21689504 ↗
• MalfunctionFeb 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT A COMPLAINT. IT WAS REPORTED THAT 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 21335383 ↗
• MalfunctionJan 15, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 21160435 ↗
• MalfunctionSep 17, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 20234837 ↗
• MalfunctionSep 5, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 20145578 ↗
• MalfunctionJan 3, 2024Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DAMAGED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS SINCE LAST REPAIR OR SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433343 ↗
• MalfunctionMar 9, 2023Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN HEAD. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND ON EVALUATION DUE TO BROKEN FOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511102 ↗
• MalfunctionNov 23, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH UNSPECIFIED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850725 ↗
• MalfunctionSep 27, 2022Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DEFECTIVE BEARING MECHANISM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO LEG OF THE ATTACHMENT WAS BENT. DATE OF EVENT NOTIFICATION:(B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493511 ↗
• MalfunctionSep 13, 2022Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOOSE PARTS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO DETACHED LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15408565 ↗
• MalfunctionFeb 7, 2022Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT CUT BY TOOL. 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 13469916 ↗
• MalfunctionFeb 3, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF CHIPPED FOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13435707 ↗
• MalfunctionSep 27, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED FOOT. 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 12538019 ↗
• MalfunctionSep 16, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED PARTS AND BEARING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR AND REASON FORE RETURN. UPON ANALYSIS, IT WAS NOTED THAT THE FOOT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485389 ↗
• MalfunctionSep 2, 2021Material Puncture/Hole; Difficult to Remove; Material Puncture/Hole; Difficult to Remove

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL GOT STUCK. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO FOOT FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418684 ↗
• MalfunctionJul 29, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PARTS DETACHED AND CUT FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PROCEDURE DELAY AND NO ADDITIONAL INTERVENTIONS PERFORMED BECAUSE OF THE EVENT. IT WAS ALSO REPORTED THAT NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250026 ↗
• MalfunctionJun 18, 2021Overheating of Device; Naturally Worn; Overheating of Device; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. ON FOLLOW UP, IT WAS REPORTED AND CONFIRMED WITH HEALTHCARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED, REASON FOR RETURN WAS OVERHEATING AND WORN BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12023775 ↗
• MalfunctionFeb 24, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DAMAGE AND DETACHED PART. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ON FOLLOW UP, IT WAS CONFIRMED THAT THE EVENT HAPPENED DURING MILLING OF THE CRANIAL FLAP. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT IMPACT, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375240 ↗
• MalfunctionFeb 2, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING MILLING OF THE CRANIAL FLAP, THERE WAS NO PROCEDURE DELAY, AND THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED. 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 11266780 ↗
• MalfunctionJan 8, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PARTS (BEARING) FELL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. UPON ANALYSIS, IT WAS NOTED THAT THE FOOT WAS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11141540 ↗
• MalfunctionJan 6, 2021Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL INSERTION DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. UPON ANALYSIS, IT WAS NOTED THAT THE FOOT WAS CUT. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS A PROCEDURE DELAY AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS NO FURTHER INFORMATION THAT CAN BE PROVIDED REGARDING THE STATUS OF THE PATIENT POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126069 ↗
• MalfunctionDec 18, 2020Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TOOL INSERTION DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. UPON ANALYSIS, IT WAS NOTED THAT THE FOOT WAS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11041620 ↗
• MalfunctionOct 23, 2020Material 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. UPON ANALYSIS, IT WAS NOTED THAT PART OF THE FOOT WAS DETACHED. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730903 ↗
• MalfunctionSep 24, 2020Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF UNABLE TO INSERT TOOL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOTED UPON ANALYSIS THAT THE FOOT WAS CUT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10581045 ↗

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)