Midas Rex® AF01RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994469151), received between Mar 28, 2018 and Dec 21, 2022 — classified as 5 malfunctions.

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

• MalfunctionDec 21, 2022Break; Material Puncture/Hole; Detachment of Device or Device Component; Break; Material Puncture/Hole; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BROKEN FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022353 ↗
• MalfunctionAug 25, 2022Break; Overheating of Device; Material Puncture/Hole; Break; Overheating of Device; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING AND BROKEN PARTS. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291331 ↗
• MalfunctionMar 30, 2021Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED LEG AND FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT, THERE WAS NO PROCEDURE DELAY AND THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT HAD NO FURTHER ISSUES POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587987 ↗
• MalfunctionOct 23, 2020Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. UPON ANALYSIS IT WAS NOTED THAT THE LEG WAS BENT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THE EVENT OCCURRED DURING A CRANIOTOMY PROCEDURE, AND THERE WAS NO IMPACT OR ISSUES WITH THE PATIENT POST-SURGERY. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE, NO ADDITIONAL ACTIONS REQUIRED, AND A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731111 ↗
• MalfunctionMar 28, 2018Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS A DELAY ON PROCEDURE, APPROXIMATELY 10 MINUTES BUT NO ADDITIONAL OR NON-ROUTINE ACTIONS WERE TAKEN. THE DELAY WAS TO GET ANOTHER ATTACHMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7380160 ↗

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)