MIDAS REX MR8 MR8-AD03 (UDI 00763000440978)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000440978), received between Jan 26, 2025 and Jul 6, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Difficult to Remove

  IT WAS REPORTED THAT THE ATTACHMENT GOT STUCK IN THE MOTOR. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION STATED THAT NEEDLE ROLLER BEARING IS STUCK IN THE FRONT HOUSING MADE THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713523 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATION FOR USE OF THE PRODUCT, A BEARING PROBLEM WAS IDENTIFIED, SPECIFICALLY THAT A BALL BEARING HAD FALLEN OUT AND WAS MISSING. IT WAS REPORTED THAT THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25454893 ↗
• InjuryMar 30, 2026Device Remains Activated

  IT WAS REPORTED THAT DURING CRANIOTOMY ATTACHMENT AND MOTOR DID NOT STOP WHEN REDUCING RESISTANCE. THERE WAS A PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED STATING THAT DURING PERFORATION OF THE SKULL THE PERFORATOR PLUNGED INTO THE SINUS, A BLEED OCCURRED AND THERE WAS A LOSS OF 500 CC OF BLOOD. IT WAS ALSO REPORTED THAT THIS ATTACHMENT AND MOTOR HAVE BEEN USED WITH THE DISPOSABLE PERFORATOR WHICH PLUNGED INTO THE SINUS.

  Patient problems: Perforation

  MAUDE report 24722436 ↗
• InjuryFeb 5, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT PATIENT HAVE LARGE BREACH OF THE DURA MATER DURING USE.

  Patient problems: Dural Tear; Insufficient Information

  MAUDE report 24267202 ↗
• MalfunctionDec 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724097 ↗
• MalfunctionNov 24, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT ELECTRIC DRILL IS OVERHEATED AND THE PATIENT WAS BURNED ON THE CHEST DUE TO THIS SURGERY WAS EXTENDED WHICH IS LESS THAN 1 HOUR. NO PATIENT IMPACT REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23629063 ↗
• MalfunctionNov 10, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508355 ↗
• MalfunctionSep 2, 2025Overheating of Device; Vibration; Noise, Audible; Overheating of Device; Vibration; Noise, Audible

  ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 22935718 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684945 ↗
• MalfunctionMar 24, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675421 ↗
• MalfunctionFeb 13, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21372680 ↗
• MalfunctionJan 26, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO REASON FOR RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237260 ↗