Midas Rex® AF02-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994422224), received between Dec 4, 2017 and Mar 26, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT CUT BY TOOL. NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9882496 ↗
• MalfunctionDec 3, 2018Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF A BENT FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR ESCALATED TO PRODUCT EVENT DUE TO DECONTAMINATION FINDING OF A CUT FOOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124456 ↗
• MalfunctionNov 21, 2018Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DAMAGED, BENT FOOT AND DETACHED PART. REPAIR ESCALATED TO PRODUCT EVENT DUE TO DECONTAMINATION FINDING OF CUT FOOT. ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THERE WAS NO DELAY ON THE PROCEDURE AS THE DAMAGE WAS IDENTIFIED DURING DEVICE CLEANING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094254 ↗
• MalfunctionMay 10, 2018Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT DUE TO DECONTAMINATION FINDING OF ATTACHMENT FOOT CUT BY A TOOL. ON FOLLOW-UP, IT WAS REPORTED THAT THIS DEVICE HAS NOT BEEN USED FOR 80 MONTHS. THE DEVICE WAS RETURNED BY SALES REP FOR SERVICING. IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504420 ↗
• MalfunctionDec 4, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO PRODUCT EVENT DUE TO DECONTAMINATION FINDING OF FOOTED PORTION CUT BY TOOL CONTACT. ON FOLLOW UP, IT WAS REPORTED THAT ANOTHER DEVICE WAS USED AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7080150 ↗

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)