MIDAS REX MR8 MR8-AVS14 (UDI 00763000441395)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00763000441395), received between Feb 21, 2025 and Sep 30, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951561 ↗
• MalfunctionSep 29, 2026Naturally Worn

  It was reported that the device had bad bearings. It was unknown if there was any patient involvement or complications as a result of the event.

  Patient problems: Insufficient Information

  MAUDE report 50927068 ↗
• MalfunctionSep 27, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50909616 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893651 ↗
• MalfunctionSep 16, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787636 ↗
• MalfunctionAug 26, 2026Naturally Worn

  It was reported that during preop the attachment was worn.  It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451540 ↗
• MalfunctionJun 29, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT LOOSE WASHER WAS OBSERVED INSIDE THE ATTACHMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649613 ↗
• MalfunctionJun 29, 2026Naturally Worn

  IT WAS REPORTED THAT BROKEN LOOSE BEARING WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649546 ↗
• MalfunctionJun 29, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT HAD LOOSE BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648822 ↗
• MalfunctionJun 25, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING FIELD SERVICING IT WAS DIFFICULT TO INSERT TOOL / BLADE .AT THE TIME OF REPORT NO PATIENT OR STAFF IMPACT IS BEEN OBSERVED. ADDITIONAL INFORMATION RECEIVED STATING THAT BEARINGS WERE SEIZED DURING THE EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618698 ↗
• MalfunctionJun 23, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT HAS LOOSE BEARINGS. AT THE TIME OF EVENT, THERE IS NO PATIENT INVOLVEMENT AND IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591579 ↗
• MalfunctionJun 23, 2026Overheating of Device

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25590824 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING. AT THE TIME OF THE REPORT, IMPACT TO THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED DURING FOLLOW UP STATING THIS ATTACHMENT WAS FOUND TO HAVE DEBRIS IN IT AND WAS PUT IN THE SPD REPAIR BIN.

  Patient problems: Insufficient Information

  MAUDE report 25503630 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT ATTACHMENT WAS OVERHEATING DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473158 ↗
• MalfunctionJun 5, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405894 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330523 ↗
• MalfunctionMay 28, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PLANNED MAINTENANCE (PM) THE DEVICE WAS OBSERVED TO HAVE A TEMPERATURE INCREASE. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325133 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRA OPERATIVELY, THE ATTACHMENT BEARING WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300863 ↗
• MalfunctionMay 21, 2026Overheating of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE HAD TEMPERATURE INCREASE DURING SERVICING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244401 ↗
• MalfunctionMay 19, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE HAD A DIFFICULTY IN INSERTION OF TOOL . NO KNOWN PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED THAT DURING EVALUATION THE BEARINGS WERE FOUND TO BE MISALIGNED .

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212330 ↗
• MalfunctionMay 18, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAD A TEMPERATURE INCREASE DURING SERVICING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203755 ↗
• MalfunctionApr 9, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF BROKEN. IT WAS REPORTED THAT 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 24826770 ↗
• MalfunctionApr 3, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT HAD SEIZED. THERE WAS NO KNOWN PATIENT IMPACT OR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778944 ↗
• MalfunctionMar 24, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672527 ↗
• MalfunctionMar 4, 2026Corroded

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504483 ↗