Midas Rex® AD03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994418876), received between Oct 16, 2018 and Feb 18, 2025 — classified as 3 injuries, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Fluid/Blood Leak; Overheating of Device; Material Deformation; Fluid/Blood Leak; Overheating of Device; Material Deformation

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF GETS VERY HOT DURING USE AND A BROWN LIQUID COMES OUT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400346 ↗
• MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399565 ↗
• MalfunctionFeb 13, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372333 ↗
• MalfunctionJun 14, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT GOT JAMMED. 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 17124001 ↗
• InjuryFeb 25, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATED AND BURNED THE SURGEON'S HAND. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE EVENT HAPPENED DURING A CRANIOTOMY PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, THERE WAS NO PROCEDURE DELAY, AND THERE WAS NO ADDITIONAL INTERVENTIONS REQUIRED BECAUSE OF THE EVENT. IT WAS ALSO REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE STATUS OF THE SURGEON AFTER THE SURGERY.

  Patient problems: Burn(s)

  MAUDE report 11381899 ↗
• InjuryAug 20, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, A NON-MEDTRONIC CODMAN (INTEGRA) PERFORATOR WAS USED WITH A MEDTRONIC EM200 AND AN AD03 AND IT WAS REPORTED THAT IT DID NOT STOP WHICH CAUSED PERFORATION OF THE DURA.

  Patient problems: Perforation

  MAUDE report 10434823 ↗
• InjuryApr 3, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIAL SURGERY, THE AD03 ALONG WITH EM100 AND A NON MDT PERFORATOR DID NOT STOP AND PERFORATED THE DURA MATER. IT WAS ALSO REPORTED THERE WAS A 10-MINUTE DELAY IN PROCEDURE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE DELAY WAS FOR THE SURGEON TO GET A BACK UP DEVICE. THE CASE WAS COMPLETED WITH NO OTHER NON-ROUTINE ACTIVITIES AND THE PATIENT SUSTAINED NO OTHER INJURIES POST-SURGERY.

  Patient problems: Perforation

  MAUDE report 8477711 ↗
• MalfunctionOct 16, 2018Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING THE CASE, THE AD03 DEVICE DIDN'T STOP WHEN IT WAS SUPPOSED TO. IT COULD HAVE HIT THE DERMA LAYER BUT A HEMATOMA PREVENTED THAT FROM HAPPENING. NO PATIENT IMPACT WAS INITIALLY REPORTED. ON FOLLOW-UP IT WAS CONFIRMED THAT THE HEMATOMA WAS PRESENT BEFORE THE OPERATION AND WAS THE INDICATION FOR THE PROCEDURE. THERE WAS NO PATIENT/STAFF IMPACT OR DELAY DUE TO THE SAID MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970017 ↗

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)