MIDAS REX MR8 MR8-AA07 (UDI 00763000440800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00763000440800), received between May 22, 2024 and Sep 30, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Naturally Worn

  It was reported that a bearing problem was observed in the attachment. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942157 ↗
• InjurySep 28, 2026No Apparent Adverse Event

  It was reported that customer had a dissatisfaction with the attachment. Additional details regarding patient impact is being followed up from the facility.

  Patient problems: Insufficient Information

  MAUDE report 50910821 ↗
• MalfunctionSep 25, 2026Difficult to Insert

  It was reported that it was difficult to insert the tool into the attachment prior to use. At the time of report, there was no patient or staff impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893912 ↗
• MalfunctionSep 25, 2026No Apparent Adverse Event

  Medtronic received information regarding a planned maintenance, and no alleged product deficiencies were reported. There was no patient impact in this event. Additional information received on evaluation that bearings were detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893560 ↗
• MalfunctionSep 24, 2026Difficult to Insert

  It was reported that during pre-operative preparation for use, there was difficulty with the insertion of tool. There was no patient impact in this event. Additional information received on evaluation that bearings were misaligned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877584 ↗
• MalfunctionSep 10, 2026Overheating of Device; Loss of Power; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716343 ↗
• MalfunctionAug 11, 2026Overheating of Device; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207039 ↗
• MalfunctionJul 3, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700949 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691900 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DEVICE WAS DEFECTIVE. AT THE TIME OF REPORT 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 25668586 ↗
• MalfunctionJun 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD DISSATISFACTION WITH THE PRODUCT. AT THE TIME OF REPORT THERE WAS NO PATIENT WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED STATING THAT BEARINGS WERE DETACHED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632624 ↗
• MalfunctionJun 25, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE IS NOT WORKING PROPERLY . IT WAS REPORTED THAT THERE IS 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 25622697 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING BEARINGS WERE BROKEN WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605321 ↗
• MalfunctionJun 24, 2026Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605228 ↗
• MalfunctionJun 23, 2026Loss of Power

  IT WAS REPORTED THAT THE MOTOR WAS NOT SPINNING. THERE WAS NO PATIENT IMPACT IN THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON EVALUATION THAT BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591477 ↗
• MalfunctionJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ATTACHMENT WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578964 ↗
• MalfunctionJun 22, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574850 ↗
• MalfunctionJun 22, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT HAS LOCKING PROBLEM. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574319 ↗
• MalfunctionJun 22, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT BUR WONT BE FIXED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574231 ↗
• MalfunctionJun 22, 2026Loss of Power

  IT WAS THAT ATTACHMENT HAD LOSS OF POWER ISSUE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574085 ↗
• MalfunctionJun 22, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573974 ↗
• MalfunctionJun 22, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT BUR WONT BE FIXED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573347 ↗
• MalfunctionJun 17, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT HAS LOCKING PROBLEM. IT WAS REPORTED THAT 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 25531688 ↗
• MalfunctionJun 17, 2026Difficult to Remove

  IT WAS REPORTED THAT THE BUR IS STUCK IN ATTACHMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BROKEN BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530474 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING OBSERVED. IT WAS REPORTED THAT THERE WAS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25515892 ↗