Midas Rex® ASMCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994418814), received between Apr 28, 2017 and Apr 17, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853995 ↗
• MalfunctionSep 9, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DISSECTING TOOL DOES NOT ATTACH. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167774 ↗
• InjuryJun 14, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A KNEE CASE, WHEN THE SURGEON WAS REVIEWING IMAGING POST SURGERY, THAT THE BEARING WAS IDENTIFIED LEFT IN THE PATIENT. IT WAS REPORTED THAT THE SURGEON DID NOT FEEL THAT THE BEARING NEEDED TO BE REMOVED. ON FOLLOW UP IT WAS STATED THAT THE PATIENT WAS REPORTED TO BE DOING WELL POST SURGERY. IT WAS ALSO REPORTED THAT THE HOSPITAL REFUSED TO RETURN THE DEVICE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 7603704 ↗
• InjuryApr 28, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BROKE DURING THE SURGERY, AND A POSTOPERATIVE SCAN WAS REQUIRED. IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, INCLUDING THE RESULTS OF THE SCAN, AND PATIENT STATUS WERE UNSUCCESSFUL.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6531876 ↗

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)