Midas Rex AS08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000084790), received between Sep 25, 2024 and Jun 30, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS GENERAL DISSATISFACTION. 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 25663220 ↗
• MalfunctionJun 15, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, BEARING WAS DEFECT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING MISALIGNED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500937 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT, PRIOR TO USE AND DURING PRE-OPERATIVE PREPARATION, A DEVICE EXHIBITED BEARING ISSUES. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467730 ↗
• MalfunctionJun 2, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25369221 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE IS A SMALL SCREW THAT IS BROKEN INSIDE. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268133 ↗
• MalfunctionApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS DEFECT AFTER THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS MISALIGNED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922232 ↗
• MalfunctionApr 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS A GENERIC ISSUE.IT WAS REPORTED THAT THERE WAS NO PATINET INVOLVEMENT.ADDITIONAL INFORMATION RECEIVED STATED THAT THE DISTAL BEARINGS GOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764033 ↗
• MalfunctionMar 20, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF UNABLE TO LOCK THE TOOL . IT IS REPORTED THAT THERE IS NO PATIENT INVOLVEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646601 ↗
• MalfunctionFeb 13, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372510 ↗
• MalfunctionSep 25, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299988 ↗