Midas Rex MR8 MR8-AA15 (UDI 00643169912359)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169912359), received between Nov 21, 2022 and Sep 23, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the device was defective. There was no patient impact. Additional information received upon evaluation stating that the bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863666 ↗
• MalfunctionSep 9, 2026Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50684713 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. 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 25687977 ↗
• MalfunctionJul 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE DETACHED BEARINGS INSIDE THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25687720 ↗
• MalfunctionJul 1, 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 BROKEN WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677722 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER EVALUATION STATING THAT DETACHED BEARINGS WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676199 ↗
• MalfunctionJun 30, 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 25668057 ↗
• MalfunctionJun 30, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WILL WON'T BE FIXED WITH BUR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663659 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT HAS BEARING PROBLEM. THERE WAS NO PATIENT INVOLVED.ADDITIONAL INFORMATION RECEIEVD STATING THAT THE BEARINGS INSIDE THE DEVICE WERE BROKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663033 ↗
• MalfunctionJun 30, 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 25662952 ↗
• MalfunctionJun 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ALLEGED ISSUE WAS UNKNOWN DEFECT. AT THE TIME OF REPORT, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED UPON EVALUATION STATING THAT THE BEARING WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646324 ↗
• MalfunctionJun 12, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING PRE-OPERATION THE ATTACHMENT HAD LOCKING ISSUE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486826 ↗
• MalfunctionJun 10, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE BEARINGS ARE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461221 ↗
• MalfunctionJun 10, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT GETS HOT. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459465 ↗
• MalfunctionMay 6, 2026No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DEVICE WITH NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT NO PATIENT WAS IMPACTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091649 ↗
• MalfunctionApr 8, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT HAD LOCK OR ADJUSTMENT RING STICKING. NO KNOWN PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814296 ↗
• MalfunctionApr 8, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE HANDPIECE WAS DEFECTIVE. THERE WAS NO PATIENT IMPACT AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED THAT THE BEARINGS WERE DETACHED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812319 ↗
• MalfunctionApr 3, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775640 ↗
• MalfunctionMar 26, 2026No Apparent Adverse Event

  IT IS REPORTED THAT THE DEVICE WITH GENERAL DISSATISFACTION. IT IS REPORTED THAT 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 24699395 ↗
• MalfunctionMar 24, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT WAS OBSERVED TO SHAKE AND MAKE NOISE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678256 ↗
• MalfunctionMar 20, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO USE ATTACHMENT DOES NOT LOCK THE DRILLS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647209 ↗
• MalfunctionFeb 18, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 24374884 ↗
• MalfunctionAug 14, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802456 ↗
• MalfunctionMay 22, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22069265 ↗
• MalfunctionMar 20, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651596 ↗