Midas Rex® AF01Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00721902481840), received between Apr 11, 2018 and Jun 30, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25664012 ↗
• MalfunctionMay 18, 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 BEARINGS AND BROKEN DRILL WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197383 ↗
• MalfunctionMay 8, 2026Naturally Worn

  IT WAS REPORTED THAT PRE-OPERATIVE PREPARATION FOR USE THE INTERNAL BEARINGS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. ADDITIONAL INFORMATION ON EVALUATION RECEIVED THAT THE BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121094 ↗
• MalfunctionMar 22, 2024Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BENT LEG . 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 18961590 ↗
• MalfunctionFeb 8, 2024Break; Material Puncture/Hole; Break; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT BROKEN. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18665937 ↗
• MalfunctionMay 2, 2023Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO LEG OF THE ATTACHMENT IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16851896 ↗
• MalfunctionNov 30, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884623 ↗
• MalfunctionNov 21, 2022Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BENT ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832611 ↗
• MalfunctionNov 7, 2022Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO BENT LEG. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT AND EVENT WAS BEING FOLLOWED UP FROM THE FACILITY. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749998 ↗
• MalfunctionOct 14, 2022Misconnection; Material Twisted/Bent; Misconnection; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TWIST WICK HOLDER ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO BENT LEG. DATE OF EVENT NOTIFICATION - (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15604382 ↗
• MalfunctionOct 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN TIP AND DETACHED BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT I NVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525818 ↗
• MalfunctionAug 23, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN COMPONENT. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF BROKEN LEG/FOOT. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. DATE OF NOTIFICATION:2022-04-21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274891 ↗
• MalfunctionJul 29, 2022Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF WORN BEARING. NO PATIENT IMPACT WAS REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DAMAGED BENT LEG. 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 15130925 ↗
• MalfunctionJul 13, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULT TO INSERT TOOL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT DUE TO ANALYSIS FINDINGS OF BENT LEG. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998113 ↗
• MalfunctionJul 12, 2022Break; Material Puncture/Hole; Detachment of Device or Device Component; Break; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED LEG. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984398 ↗
• MalfunctionJul 1, 2022Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO BENT LEG. DATE OF NOTIFICATION: 2022-MAR-17.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883695 ↗
• MalfunctionAug 3, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT BENT. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW-UP, THERE WAS NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271527 ↗
• MalfunctionApr 9, 2021Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. UPON ANALYSIS, IT WAS NOTED THAT THE LEG WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645974 ↗
• MalfunctionFeb 17, 2021Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. UPON ANALYSIS, IT WAS NOTED THAT THE LEG WAS BENT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE, THERE WERE NO ADDITIONAL INTERVENTIONS PERFORMED, THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337819 ↗
• MalfunctionFeb 12, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BENT FOOT. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE EVENT OCCURRED DURING A CRANIOTOMY PROCEDURE AND THERE WAS NO IMPACT OR ISSUES WITH THE PATIENT POST-SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE AND NO ADDITIONAL ACTIONS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324689 ↗
• MalfunctionJan 21, 2021Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. UPON ANALYSIS, IT WAS NOTED THAT THE LEG WAS BENT. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO PROCEDURE DELAY AND A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11211084 ↗
• MalfunctionJun 16, 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 EVALUATION, IT WAS NOTED THAT THE LEG OF THE ATTACHMENT WAS BENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10158723 ↗
• MalfunctionDec 22, 2019Overheating of Device; Material Puncture/Hole; Overheating of Device; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. NO FURTHER INFORMATION REGARDING PATIENT OR STAFF IMPACT. UPON ANALYSIS, IT WAS NOTED THAT THE LEG WAS BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9508646 ↗
• MalfunctionJun 20, 2019Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Patient Involvement

  MAUDE report 8716011 ↗
• MalfunctionApr 11, 2018Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF END OF BUR GUARD IS BROKEN OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 7421247 ↗

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)