Midas Rex MR8 MR8-AF02 (UDI 00643169912403)Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00643169912403), received between May 17, 2021 and Sep 28, 2026 — classified as 1 injury, 188 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (69 reports).

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 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Overheating of Device

  It was reported that the attachment with the report of temperature increase. It was reported that there was no known patient impact. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50911026 ↗
• MalfunctionSep 25, 2026Naturally Worn

  It was reported that the bearings were broken. It was reported that there was no patient involvement. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895041 ↗
• MalfunctionSep 23, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient impact reported. Additional information was received stating that loose bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865712 ↗
• MalfunctionSep 15, 2026No Apparent Adverse Event

  It was reported that the device was defective. There was no patient impact. Additional information received stating that the distal bearing got detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777512 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that ball bearing fell out / missing. No patient involvement and impact was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769372 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that the bearings were missing from the device. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768344 ↗
• MalfunctionSep 15, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported that there was no patient involvement. Additional information was received stating that bearings were detached found in analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768259 ↗
• MalfunctionSep 9, 2026Naturally Worn

  It was reported that prior to use, the bearing was broken. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683655 ↗
• MalfunctionAug 28, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50494079 ↗
• MalfunctionAug 28, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493097 ↗
• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the cannot insert the tool in the attachment. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272453 ↗
• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the attachment no longer connects to the drill. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268818 ↗
• MalfunctionJul 28, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. There was no known patient impact reported. Additional information was received stating that distal bearing detached were found during evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50049028 ↗
• MalfunctionJul 6, 2026Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF REMOVAL DIFFICULTY AND NOISE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714559 ↗
• MalfunctionJul 3, 2026Difficult to Insert

  IT WAS REPORTED THAT DIFFICULT TO INSERT ON MOTOR. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702873 ↗
• MalfunctionJul 3, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702160 ↗
• MalfunctionJul 3, 2026Difficult to Insert

  IT WAS REPORTED THAT IMPOSSIBLE TO LOCK ON THE MOTOR. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702146 ↗
• MalfunctionJul 3, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAD BEARINGS BROKEN. THERE IS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700981 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25689857 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25689800 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS GENERAL DISSATISFACTION. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689280 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT A ATTACHMENT WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688585 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688285 ↗
• MalfunctionJul 2, 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 BEARINGS ARE DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687565 ↗
• MalfunctionJul 1, 2026Overheating of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING SUPRATENTORIAL HEMISPHERIC TUMOR RESECTION BY OSTEOPLASTIC CRANIOTOMY PROCEDURE THE CUTTER/TOOL WAS STUCK INSIDE THE ATTACHMENT, ALSO THE ATTACHMENT APPEARED HOT FROM THE BEGINNING OF THE DRILLING AND REMAINED HOT AFTER SWITCHING TO THE CRANIOTOMY PROCEDURE. AT THAT TIME, THE ENTIRE CUT THROUGH THE BONY TABLE COULD BE COMPLETED, SO THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680628 ↗