MIDAS REX LEGEND AS08Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000440442), received between Nov 15, 2024 and May 7, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K020069, K170312); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE DOESN'T WORK WELL DURING MAINTENANCE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARING WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110126 ↗
• MalfunctionApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS DEFECT AFTER THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING MISALIGNED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924005 ↗
• MalfunctionMar 26, 2025Difficult to Insert; Overheating of Device; Difficult to Insert; Overheating of Device

  IT WAS REPORTED THAT ATTACHMENT GOT STUCK IN THE HAND PIECE. BUR UNLOCKED IN THE MIDDLE OF THE SURGERY CAUSING BOTH HANDPIECE AND THE ATTACHMENT SO HOT THAT IT BURNED THROUGH THE SCRUB NURSES GLOVES. IT WAS REPORTED THAT THERE IS NO PATIENT IMPACT. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. THERE WAS NO STAFF INJURY, ONLY DAMAGED GLOVES BY THE HEAT OF THE HANDPIECE AND NO HARM DONE TO THE PATIENT, SURGERY WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695061 ↗
• MalfunctionFeb 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OF COMPONENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340683 ↗
• MalfunctionNov 15, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020069, K170312. 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)