Midas Rex AS09Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000084806), received between Mar 17, 2025 and Jun 22, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579246 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. IT WAS REPORTED THAT 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 25556770 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515442 ↗
• MalfunctionJun 13, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARING WAS DAMAGED 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 25494849 ↗
• MalfunctionJun 10, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT BALL BEARING WAS BROKEN. 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 25455466 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component; Naturally 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 25453401 ↗
• 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 25442910 ↗
• MalfunctionJun 8, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT 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 25426359 ↗
• MalfunctionJun 6, 2026Naturally Worn

  IT WAS REPORTED THAT POST OPERATIVELY, THE ATTACHMENT BEARING WAS DEFECTIVE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418523 ↗
• MalfunctionJun 5, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARINGS OF THE ATTACHMENT WERE FOUND BROKEN PRIOR TO USE. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408708 ↗
• MalfunctionJun 5, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS SPOILED 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 25404619 ↗
• MalfunctionJun 5, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403857 ↗
• MalfunctionJun 4, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT WITH THE REPORT OF NOT ATTACHING TO HOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25389573 ↗
• MalfunctionJun 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF TOOL CANNOT BE INSERTED. IT WAS REPORTED THAT 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 25355380 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT PARTS FALL OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328584 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING PREOP THE THREADS IN THE INTERNAL CHANNEL OF THE NIPPLE APPEARB BROKEN. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25327351 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component; No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25268405 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268007 ↗
• MalfunctionMay 25, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE THE TOOL WAS NOT INSERTING INTO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DISTAL BEARINGS GOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267623 ↗
• MalfunctionMay 4, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT 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 25065584 ↗
• MalfunctionApr 9, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARING WAS BROKEN PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS ARE DETACHED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827462 ↗
• MalfunctionMar 26, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS BROKEN .NO PATIENT INVOLVEMENT OR IMPACT TO PATIENT OR STAFF OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698602 ↗
• MalfunctionSep 17, 2025Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND LOCK OR ADJUSTMENT RING STICKING.IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070504 ↗
• MalfunctionMar 17, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT AND DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619777 ↗