Midas Rex® AS08Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00721902481697), received between Jul 25, 2023 and Jul 3, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE IS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THAT BUSHING BEARINGS ARE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701437 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE DISTAL BEARING IS DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664209 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663553 ↗
• MalfunctionJun 26, 2026Vibration; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT HAS WOBBLES AND A NOISY ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DISTAL BEARING IS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643456 ↗
• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO REPORTED MALFUNCTION AT THE TIME OF INTAKE. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A FAILED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448000 ↗
• MalfunctionJun 4, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT LOCK WAS STICKING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388633 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE PARTS FALL OFF AFTER THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329393 ↗
• MalfunctionMay 27, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAS LOOSE BEARING AND DRILL BIT WONT LOCK PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARING WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296586 ↗
• 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 BEARINGS MISALIGNED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923061 ↗
• MalfunctionFeb 19, 2025Overheating of Device; Naturally Worn; Noise, Audible; Overheating of Device; Naturally Worn; Noise, Audible

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENTS HAVE LOOSE COMPONENTS AND OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407531 ↗
• MalfunctionDec 3, 2024Loss of Power; Loss of Power

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOSS OF POWER. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828959 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454352 ↗
• MalfunctionOct 14, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE ATTACHMENTS NEEDED TO BE REPLACED DUE TO EPOXY WAS FOUND OUTSIDE THE RING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438608 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277000 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254609 ↗
• MalfunctionAug 5, 2024Detachment 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. REPAIR REQUEST ESCALATED TO P PRODUCT EVENT DUE TO REASON FOR RETURN. ON FOLLOW-UP NO FURTHER INFORMATION WAS PROVIDED ON PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905124 ↗
• MalfunctionNov 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS. ON FOLLOW UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT AND THE PROCEDURE PERFORMED WHEN THE EVENT OCCURRED WAS CRANIOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18157453 ↗
• MalfunctionNov 16, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148510 ↗
• MalfunctionNov 7, 2023Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE THE REPORT OF WITH UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082092 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660747 ↗
• InjuryJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE NEUROSURGERY OPERATION IN THE SPINE DEPARTMENT, THE STEEL BALL IN THE BEARING FELL INTO THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT POSTOPERATIVE IMAGING EXAMINATION CONFIRMED THE STEEL BALL LEFT IN THE PATIENT'S BODY. THE PROCEDURE COMPLETED USING BACKUP PRODUCT. ON FOLLOW-UP NO FURTHER INFORMATION WAS PROVIDED AND THE CUSTOMER REFUSED TO RETURN THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure

  MAUDE report 17388390 ↗

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)