MIDAS REX MR8 MR8-AS14 (UDI 00763000441074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000441074), received between Aug 28, 2024 and Sep 27, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (18 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910412 ↗
• MalfunctionAug 26, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461133 ↗
• MalfunctionJul 6, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE THE DEVICE HAD LOOSE INTERNAL COMPONENTS IN IT. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT IMPACT IN THIS IMPACT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT THE BEARINGS WERE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713528 ↗
• MalfunctionJun 30, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WOULD NOT HOLD DRILL BIT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665314 ↗
• MalfunctionJun 29, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING TESTING AND MAINTENANCE, ATTACHMENT FAILURE WAS OBSERVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648620 ↗
• MalfunctionJun 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THE THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619785 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT LOOSE BEARING WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617439 ↗
• MalfunctionJun 24, 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 25606274 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578671 ↗
• MalfunctionJun 21, 2026Corroded

  IT WAS REPORTED THAT BIOBURDEN WAS OBSERVED ON THE DEVICE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572296 ↗
• MalfunctionJun 18, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PRE OPERATIVELY, TEMPERATURE INCREASED. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATED THAT INTERNAL TUBE BEARING WAS MISALIGNED MADE THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543653 ↗
• MalfunctionJun 16, 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 25514683 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE GASKET MISSING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501204 ↗
• MalfunctionJun 14, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT DEVICE HAS LOCKING AND BEARING ISSUE 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 25497617 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING PREVENTIVE MAINTENANCE. IT WAS REPORTED THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487831 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS FOUND TO BE OVERHEATING DURING PREVENTIVE MAINTENANCE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481575 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT THERE WAS BROKEN BUSHING INSIDE THE DEVICE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MISALIGNED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474425 ↗
• MalfunctionJun 11, 2026Naturally Worn

  IT WAS REPORTED THAT METAL BROKE AND WAS MOVING INSIDE THE DEVICE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO PATIENT IMPACT AND THE BEARING WAS MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467619 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444448 ↗
• MalfunctionJun 9, 2026Overheating of Device

  IT WAS REPORTED THAT OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439172 ↗
• MalfunctionJun 8, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE OVERHEATING AND BEARING WAS WORN OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425730 ↗
• MalfunctionJun 7, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING OBSERVED DURING A USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25420749 ↗
• MalfunctionJun 6, 2026Difficult to Remove

  IT WAS REPORTED THAT BRUSH BRISTLE STUCK INSIDE ATTACHMENT. AT THE TIME OF REPORT, PATIENT IMPACT WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418646 ↗
• MalfunctionJun 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OF OVERHEATING. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25365852 ↗
• MalfunctionMay 26, 2026Naturally Worn

  IT WAS REPORTED THAT DURING USE, BEARING IN ATTACHMENT FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279565 ↗