MIDAS REX LEGEND T14MH25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000061968), received between Apr 18, 2025 and Apr 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL COMPLAINED THAT THE STYLUS MOTOR WAS HEATING UP DURING THE SURGERY AND THE BUR BROKE SUBSEQUENTLY. A SECOND BUR ( SAME LOT NUMBER) WAS USED TO REPLACED THE BROKEN BUR, THE SAME INCIDENT HAPPENED. A THIRD BUR WAS USED TO REPLACE THE BROKEN BUR AND THE HCP MANAGED TO FINISH THE SURGERY. BROKEN PIECES OF THE TOOL WERE FOUND IN THE PATIENT WHICH WERE LATER RETRIEVED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT, AND THERE WAS A DELAY OF 10 MINUTES (2 TIMES TROUBLESHOOTING AS 2 BURS BROKE DURING THE SURGERY) DURING DELAY BURRS WERE REPLACED. IT WAS ALSO REPORTED THAT THERE WAS NO PROLONGED EXPOSURE TO ANESTHESIA AND NO INTERVENTION WAS PERFORMED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21863320 ↗
• MalfunctionApr 18, 2025Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL COMPLAINED THAT THE STYLUS MOTOR WAS HEATING UP DURING THE SURGERY AND THE BUR BROKE SUBSEQUENTLY. A SECOND BUR (SAME LOT NUMBER) WAS USED TO REPLACED THE BROKEN BUR; THE SAME INCIDENT HAPPENED. A THIRD BUR WAS USED TO REPLACE THE BROKEN BUR AND THE HCP MANAGED TO FINISH THE SURGERY. BROKEN PIECES OF THE TOOL WERE FOUND IN THE PATIENT WHICH WERE LATER RETRIEVED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT, AND THERE WAS A DELAY OF 10 MINUTES (2 TIMES TROUBLESHOOTING AS 2 BURS BROKE DURING THE SURGERY) DURING DELAY BURRS WERE REPLACED. IT WAS ALSO REPORTED THAT THERE WAS NO PROLONGED EXPOSURE TO ANESTHESIA AND NO INTERVENTION WAS PERFORMED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21863304 ↗

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)