Midas Rex MR8 MR8-AS14-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000063634), received between Oct 28, 2024 and Sep 30, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (11 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component; Noise, Audible

  It was reported that the attachment drill and green 14 cm attachment were in use they were making a strange noise and question something wrong with drill but definitely bearings gone in 14 cm attachment. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943030 ↗
• 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 misaligned distal bearing was found during evaluation made it reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893490 ↗
• MalfunctionAug 26, 2026Naturally Worn

  It was reported that during use the bearings failed. No patient involvement was reported. Additional information was received stating that loose bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50445127 ↗
• MalfunctionAug 3, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117543 ↗
• MalfunctionJun 30, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667952 ↗
• MalfunctionJun 30, 2026Naturally Worn

  IT WAS REPORTED THAT DURING USE THE BEARINGS IN THE ATTACHMENT FAILED. THERE WAS NO PATIENT IMPACT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663609 ↗
• MalfunctionJun 25, 2026Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT HAS MAKING CRACKLING NOISE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623094 ↗
• MalfunctionJun 22, 2026Naturally Worn

  IT WAS REPORTED THAT DURING USE, THE ATTACHMENT BEARING HAD FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25575058 ↗
• MalfunctionJun 17, 2026Loss of Power

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538556 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BALL BEARING ARE GONE PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515474 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT BEARINGS WERE GONE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515230 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT 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 25514042 ↗
• MalfunctionJun 15, 2026Smoking

  IT WAS REPORTED THAT THE DEVICE WAS EMITTING SMOKE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498043 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING CHIPPED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482862 ↗
• MalfunctionJun 9, 2026Device Reprocessing Problem

  IT WAS REPORTED THAT PRIOR TO USE, BRISTLES WERE STUCK IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446079 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT BEARINGS FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391354 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE; THE ATTACHMENT INTERNAL BEARINGS WERE MISALIGNED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390862 ↗
• MalfunctionMay 27, 2026Noise, Audible

  IT WAS REPORTED THAT THE BEARINGS NOISY IN ATTACHMENT DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING FAILED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296462 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE BEARING WERE DISLODGED. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934118 ↗
• MalfunctionApr 17, 2026Corroded

  IT WAS REPORTED THAT THE ATTACHMENT WAS FOUND WITH CORROSION. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE BEARING WAS MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907094 ↗
• MalfunctionMar 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING USE THE ATTACHMENT HAD BEARINGS ARE DETACHED IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529389 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BEARINGS WERE GONE PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267171 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE OP THE ATTACHMENT HAD DETACHED BEARINGS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017737 ↗
• MalfunctionOct 24, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS ALLEGED TO BE OVERHEATING, RUNNING HOT, AND HEATING UP DURING INTRAOPERATIVE USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377140 ↗
• MalfunctionOct 22, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE WITH THE REPORT OF OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355216 ↗