Midas Rex MR8 MR8-AF02-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00763000063566), received between Aug 10, 2024 and Sep 30, 2026 — classified as 100 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (26 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Loss of Power

  It was reported that during testing, device was seized. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942426 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928430 ↗
• MalfunctionSep 25, 2026Material Deformation

  It was reported that the attachment has Markings damaged/missing/illegible during the pre op. It was reported there was no patient or staff impact. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893914 ↗
• MalfunctionSep 25, 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 distal bearing misaligned was found during evaluation made this event reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893868 ↗
• MalfunctionSep 24, 2026Device Markings/Labelling Problem

  It was reported that pre-operatively during preventive maintenance (PM) the device had damaged/missing/illegible markings. There was no patient involvement during testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882958 ↗
• MalfunctionSep 17, 2026Naturally Worn

  It was reported that device had damaged cable. At the time of report patient impact or involvement was unknown. Additional information received upon communication stating that the loose bearings were found prior to use and there was no patient impact or staff impact associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798491 ↗
• MalfunctionSep 11, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734106 ↗
• MalfunctionSep 11, 2026Detachment of Device or Device Component

  It was reported that at the Sterilization and Processing Department (SPD) the device fell apart. Loose parts included a bearing, spring, and a washer. There was no patient involvement during service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733648 ↗
• MalfunctionSep 11, 2026Naturally Worn

  It was reported that loose wires were identified inside the device during post-op. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726112 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  It was reported that the device had no allegation of malfunction but there were analysis findings. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716807 ↗
• MalfunctionSep 10, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716120 ↗
• MalfunctionSep 10, 2026Overheating of Device

  It was reported that the attachment overheated. It was reported that there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707528 ↗
• MalfunctionSep 4, 2026Difficult to Insert

  It was reported that the tool was not locking. It was reported that there was no known impact to a patient. Additional information was received stating that bearing misaligned were found during evaluation.

  Patient problems: Insufficient Information

  MAUDE report 50609701 ↗
• MalfunctionAug 28, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492492 ↗
• MalfunctionAug 27, 2026Mechanical Problem

  It was reported that bearings were loose. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478341 ↗
• MalfunctionJul 1, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS NOTED TO HAVE BAD BEARINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED AS MISALIGNED BEARINGS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674403 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE HAND PIECE ATTACHMENT WAS FAULTY PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670761 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRIOR TO USE, BEARINGS RUNNING ROUGH. AT THE TIME OF REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667114 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663257 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT A BEARING ISSUE WAS IDENTIFIED WITH THE ATTACHMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663191 ↗
• MalfunctionJun 26, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS MAKING A GRINDING SOUND AND IT WAS RUNNING HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640709 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS FAULTY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623207 ↗
• MalfunctionJun 25, 2026Difficult to Remove

  IT WAS REPORTED THAT PRE-OPERATIVELY THERE WAS DEBRIS STUCK INSIDE ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619539 ↗
• MalfunctionJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25606980 ↗
• MalfunctionJun 22, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) BEARINGS WERE BAD/LOUD AND "RUNNING ROUGH". THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577805 ↗