Midas Rex AS09SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000084813), received between Mar 10, 2025 and Sep 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928966 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406026 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT PARTS FELL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25357076 ↗
• MalfunctionJun 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PARTS WERE FELL OUT PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT FRACTURE OF BEARING FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345945 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328816 ↗
• MalfunctionMay 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE PARTS FALL OFF PRIOR TO USE. IT WAS REPORTED THAT 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 25314420 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298676 ↗
• MalfunctionMay 27, 2026Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE, BALL BEARING FELL OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297937 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING 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 25296490 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273764 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE HAD THE REPORT OF PARTS FALLING OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273648 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BEFORE USE, THE PARTS WERE FELLED OFF. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862881 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769836 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE 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 22499860 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392998 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PARTS FALL OFF. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381357 ↗
• MalfunctionMar 10, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558377 ↗