Midas Rex® AS10S-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994421876), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Vibration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2018Vibration; Vibration

  IT WAS REPORTED BY THE SALES REP THAT WHILE DR. (B)(6) WAS USING THE MIDAS EHS HE QUICKLY COMPLAINED OF CHATTER, SOON FOLLOWED BY A TEAR IN THE DURA. DR (B)(6) WAS USING THE DRILL FOR BURR HOLES IN ADVANCE OF THE CRANIOTOMY, SO HE WAS ALREADY PLANNING TO EXPOSE AND CUT THROUGH THE DURA. AFTER DR. (B)(6) DID THE INITIAL BUR HOLE, HE SWITCHED ATTACHMENTS WITH THE SAME TOOL AND IT WORKED AS EXPECTED. THERE WAS A DELAY OF APPROXIMATELY FIVE MINUTES TO OPEN ANOTHER TRAY. SOME PATIENT INFORMATION WAS PROVIDED. CURRENT STATUS OF THE PATIENT WAS NOT GIVEN, NO PATIENT IMPACT REPORTED. ON MULTIPLE FOLLOW UP ATTEMPTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: Laceration(s)

  MAUDE report 7164015 ↗

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)