Midas Rex MR8 MR8-AS07-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00763000063597), received between Aug 28, 2024 and Sep 30, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  It was reported that the customer had dissatisfaction with the product. There was no patient involvement or complications as a result of the event. Additional information received that loose bearing at tube distal was observed during evaluation .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942940 ↗
• MalfunctionSep 29, 2026Insufficient Device Problem Information

  It was reported that pre-operatively the device was broken. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933201 ↗
• MalfunctionSep 24, 2026Difficult to Insert

  It was reported that it was difficult to insert the tool / blade into the device during preventive maintenance (PM). There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884853 ↗
• MalfunctionAug 27, 2026Overheating of Device

  It was reported that the device got hot. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483791 ↗
• MalfunctionJun 30, 2026Difficult to Remove

  IT WAS REPORTED THAT PRIOR TO USE BRISTLES STUCK IN THE ATTACHMENT. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MISALIGNED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666634 ↗
• MalfunctionJun 26, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HEATING UP DURING A PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632195 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARING WAS LOOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617785 ↗
• MalfunctionJun 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS DAMAGED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617516 ↗
• MalfunctionJun 25, 2026Vibration

  IT WAS REPORTED THAT DURING PRE-OP, THE ATTACHMENT WAS VIBRATING WHEN USING AND NOT DRILLING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617474 ↗
• MalfunctionJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT DURING TESTING, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605005 ↗
• MalfunctionJun 24, 2026Naturally Worn

  IT WAS REPORTED THAT DURING USE BEARINGS WERE FAILED. AT THE TIME OF REPORT NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED THAT DURING INSPECTION BEARINGS FOUND TO BE LOOSE AND DAMAGED AT THE DISTAL TUBE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604047 ↗
• MalfunctionJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS ALLEGED TO HAVE EXPERIENCED OVERHEATING DURING USE.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 25603740 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING PRIOR TO USE. 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 25591566 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT DURING MAINTENANCE, THE ATTACHMENT WAS FOUND OVERHEATING. IT WAS REPORTED 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 25590200 ↗
• MalfunctionJun 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT SMALL RINGS CAME OUT WHILE DRILLING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589963 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. 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 25589951 ↗
• MalfunctionJun 19, 2026Corroded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSPECTION THE BEARING FELL OUT/DETACHED AND THERE WAS RUST/CORROSION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561305 ↗
• MalfunctionJun 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARING WAS LOOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25558914 ↗
• MalfunctionJun 16, 2026Loss of Power

  IT WAS REPORTED THAT THE DURING USE ATTACHMENT BALL BEARING WAS NOT WORKING PROPERLY. IT WAS REPORTED 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 25516737 ↗
• MalfunctionJun 16, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514766 ↗
• MalfunctionJun 16, 2026Vibration; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS TAGGED FOR REPAIR DUE TO BEING DESCRIBED AS "WOBBLY" AND IN NEED OF NEW BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514044 ↗
• MalfunctionJun 15, 2026Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSPECTION THE BEARING FELL OUT/WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503503 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED 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 25503244 ↗
• MalfunctionJun 15, 2026Corroded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSPECTION THE BEARING WAS DETACHED AND THERE WAS CORROSION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501203 ↗
• MalfunctionJun 15, 2026Vibration

  IT WAS REPORTED THAT DURING TESTING, THE ATTACHMENT TOOL WOBBLE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499135 ↗