MIDAS REX™ AF02Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00763000084738), received between Jan 30, 2020 and Sep 9, 2026 — classified as 2 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (29 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696030 ↗
• MalfunctionJul 3, 2026Difficult to Remove

  IT WAS REPORTED THAT BURR STUCK IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700900 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE AT THE TIME OF INTAKE. 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 25692511 ↗
• MalfunctionJul 2, 2026Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF LOCK OR ADJUSTMENT RING STICKING AND DIFFICULTY WITH ASSEMBLY. 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 25688803 ↗
• MalfunctionJun 30, 2026Difficult to Insert

  IT WAS REPORTED THAT TOOL COULD NOT BE INSERTED INTO THE ATTACHMENT AFTER OPERATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662298 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE OPERATIVELY, BEARING FOUND BROKEN. AT THE TIME OF REPORT, THERE WAS NO PATIENT IMPACT AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557008 ↗
• MalfunctionJun 18, 2026Difficult to Insert

  IT WAS REPORTED THAT CUTTER HEAD COULD NOT BE INSERTED PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545667 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT, DURING PRE-OPERATIVE PREPARATION FOR USE, THE BEARING (INTERNAL TUBE) WAS FOUND TO BE BROKEN, EXHIBITED SIGNS OF BEING BAD OR LOUD ("RUNNING ROUGH"). IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534388 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. 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 25514000 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT HAD PARTS FALL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500904 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, PARTS FALL OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499286 ↗
• MalfunctionJun 13, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARING WAS PROBLEM PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494817 ↗
• MalfunctionJun 12, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING ISSUE PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484039 ↗
• MalfunctionJun 12, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT EXHIBITED BEARING ISSUES, INCLUDING BEARINGS THAT WERE BAD, LOUD, AND "RUNNING ROUGH,".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 25482631 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT THE IN THE ATTACHMENT BEARING WAS DAMAGED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE DETACHED BEARINGS INSIDE THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468092 ↗
• MalfunctionJun 11, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466380 ↗
• MalfunctionJun 10, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456881 ↗
• MalfunctionJun 10, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456810 ↗
• MalfunctionJun 10, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT BEARING WAS DAMAGED PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455707 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BEARING HAS FALLEN OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452890 ↗
• MalfunctionJun 9, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442549 ↗
• MalfunctionJun 9, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442145 ↗
• MalfunctionJun 9, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441560 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406545 ↗
• MalfunctionJun 4, 2026Difficult to Insert

  IT WAS REPORTED THAT DEVICE WITH THE BLADE COULD NOT BE INSERTED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS LOOSE WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394812 ↗