Midas Rex® AF02R (UDI 00763000084745)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000084745), received between Jun 16, 2021 and May 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING IS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328943 ↗
• MalfunctionOct 23, 2024Difficult to Insert; Difficult to Insert

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED 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 20513119 ↗
• MalfunctionSep 11, 2024Loss of Power; Detachment of Device or Device Component; Loss of Power; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF SEIZED/NOT RUNNING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188283 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958915 ↗
• MalfunctionAug 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PROBLEM NOT REPORTED. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT BASED ON EVALUATION DUE TO BEARING DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919719 ↗
• MalfunctionApr 30, 2024Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211741 ↗
• MalfunctionDec 29, 2023Material Twisted/Bent; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417627 ↗
• MalfunctionJul 17, 2022Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF TWISTED GUARD. 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 15036663 ↗
• MalfunctionOct 6, 2021Electrical /Electronic Property Problem; Material Puncture/Hole; Electrical /Electronic Property Problem; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DEVICE FROZEN AND DOES NOT RUN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO CUT FOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587117 ↗
• MalfunctionSep 1, 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 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 12411269 ↗
• MalfunctionJun 16, 2021Overheating of Device; Difficult to Remove; Noise, Audible; Overheating of Device; Difficult to Remove; Noise, Audible

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT STUCK. 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. ADDITIONAL INFORMATION RECEIVED, REASON FOR RETURN WERE OVERHEATING AND NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008575 ↗

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)