Midas Rex® PM100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00721902469657), received between Feb 3, 2020 and Jul 9, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456678 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854414 ↗
• MalfunctionApr 3, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761635 ↗
• MalfunctionFeb 21, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434793 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401668 ↗
• MalfunctionSep 18, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT SEATING PROPERLY. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO THE DETACHED COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244686 ↗
• InjuryJul 9, 2024Loss of Power; Loss of Power

  IT WAS REPORTED THAT DURING BRAIN TUMOR RESECTION UNDER GENERAL ANESTHESIA DURING SURGERY THE PNEUMATIC MOTOR STOPPED ROTATING AS SOON AS IT TOUCHED THE SKULL. IT WAS ALSO REPORTED THAT THE PATIENT WAS IN GENERAL ANESTHESIA AND REPLACING THE EQUIPMENT PROLONGED THE OPERATION TIME AND INCREASED THE RISK TO THE PATIENT. ON FOLLOW UP IT WAS REPORTED THAT PROLONGED OPERATION TIME WAS ABOUT 20 MINUTES AND THE PATIENT WAS ON A PROLONGED EXPOSURE TO ANESTHESIA DUE TO THE EVENT.

  Patient problems: Awareness During Anesthesia

  MAUDE report 19702107 ↗
• MalfunctionJul 24, 2023Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF HOSE RUPTURED. 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 17378271 ↗
• MalfunctionMar 30, 2022Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. 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 13948366 ↗
• InjuryFeb 3, 2020Electrical /Electronic Property Problem; Loss of Power; Electrical /Electronic Property Problem; Loss of Power

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT WORKING AND POOR AIR FLOW. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT BUT THERE WAS PROLONGED EXPOSURE TO ANESTHESIA AND PROCEDURE DELAY TO GET ANOTHER DRILL. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: Chemical Exposure

  MAUDE report 9662352 ↗

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)