Midas Rex MR8 MR8-AS09-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000063603), received between Dec 11, 2024 and Sep 15, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Difficult to Insert

  It was reported that the burr was not going through. There is no patient involvement reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766799 ↗
• MalfunctionAug 26, 2026Difficult to Insert

  It was reported that the straight attachment has not advancing through inner sheath. There was no patient involved. Additional information stated that the bearing was damaged found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449439 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690153 ↗
• MalfunctionJun 27, 2026Vibration; Noise, Audible

  IT WAS REPORTED THAT ATTACHMENT IS NOT WORKING PROPERLY IT IS HAVING LOUD NOISE AND VIBRATION. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DAMAGED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644922 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ATTACHMENT REPORTED WITH THE ISSUE OF FAULTY. IT WAS REPORTED 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 25623012 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS LOOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619340 ↗
• MalfunctionJun 25, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT HAD FAULTY BEARING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618588 ↗
• MalfunctionJun 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT HAD A LOOSE O-RING INSIDE/BEARINGS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604069 ↗
• MalfunctionJun 22, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT EXHIBITED OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579143 ↗
• MalfunctionJun 22, 2026Naturally Worn

  IT WAS REPORTED THAT THE DURING INTRAOP FROM ATTACHMENT BEARINGS LOOSE/COMING OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVE MENT.ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573164 ↗
• MalfunctionJun 18, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548744 ↗
• MalfunctionJun 12, 2026Difficult to Insert

  IT WAS REPORTED THAT ATTACHMENT HAD INSERTION DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AS BEARINGS MISALIGNED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25483859 ↗
• MalfunctionJun 11, 2026Vibration; Noise, Audible

  IT WAS REPORTED THAT ATTACHMENT WAS CHATTERING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466275 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, BEARINGS IN THE ATTACHMENT FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403720 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, O-RING MISSING INSIDE FROM THE ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25388175 ↗
• MalfunctionMay 19, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218733 ↗
• MalfunctionApr 7, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING FAILED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATED THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802499 ↗
• MalfunctionFeb 9, 2026Corroded

  IT WAS REPORTED THAT RUST AND CORROSION WERE OBSERVED ON THE PRODUCT WITH THE ATTACHMENT. THE ISSUE WAS FOUND IN SPD. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291744 ↗
• MalfunctionDec 11, 2024Naturally Worn; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF WORN. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903702 ↗