MIDAS REX MR8 MR8-AA15 (UDI 00763000440909)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00763000440909), received between Feb 16, 2023 and Sep 23, 2026 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Apparent Adverse Event

  It was reported that the issue with the device was unknown. At the time of report, there was no patient impact. Additional information received upon evaluation stating that the bearing was detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871152 ↗
• MalfunctionAug 26, 2026Difficult to Remove

  It was reported that the attachment was stuck. No patient impact was reported. Additional information was received stating that detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450231 ↗
• MalfunctionAug 13, 2026Difficult to Insert

  It was reported that attachment had assembly difficulty. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233033 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. 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 25714924 ↗
• MalfunctionJul 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT GETS HOT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714380 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. 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 25713510 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713508 ↗
• MalfunctionJul 5, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WERE NO ALLEGED ISSUE WITH THE DEVICE. 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 25712754 ↗
• MalfunctionJul 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS GENERAL DISSATISFACTION. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700910 ↗
• 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 25691621 ↗
• MalfunctionJul 2, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT LOCK THE CUTTER TOOL PRIOR TO ITS USE. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689090 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT INTRAOPERATIVELY THE ATTACHMENT WAS FAULTY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679993 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  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 25676256 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST WITH NO ALLEGED PRODUCT DEFICIENCY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE TOP DISTAL BEARING IS DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675115 ↗
• MalfunctionJul 1, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAS BEARING PROBLEM. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION STATED THAT THE BEARING INSIDE WAS BROKEN DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675098 ↗
• MalfunctionJun 30, 2026No 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 PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665687 ↗
• MalfunctionJun 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DISTAL BEARING IS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641702 ↗
• MalfunctionJun 26, 2026Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT WAS LOCKING NOISE PROBLEM. 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 25632410 ↗
• MalfunctionJun 24, 2026Difficult to Insert

  IT WAS REPORTED THAT BUR WON'T BE FIXED IN THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605406 ↗
• MalfunctionJun 24, 2026Difficult to Insert

  IT WAS REPORTED THAT THE BURR WON'T BE FIXED WITH AN ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605154 ↗
• MalfunctionJun 24, 2026Difficult to Insert

  IT WAS REPORTED THAT THE BURR WON'T BE FIXED WITH ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605035 ↗
• 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 25590939 ↗
• MalfunctionJun 22, 2026Difficult to Insert

  IT WAS REPORTED THAT ATTACHMENT HAD LOCKING ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574912 ↗
• MalfunctionJun 18, 2026Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TOOLS LOCKING ISSUE WITH ATTACHMENT . 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 25543055 ↗
• MalfunctionJun 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD DISSATISFACTION WITH THE PRODUCT. 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 25534295 ↗