Midas Rex MR8 MR8-AVA10 (UDI 00643169912656)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169912656), received between Nov 15, 2022 and Sep 28, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult to Insert

  It was reported that the attachment with the report of difficulty with assembly. It was reported that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911122 ↗
• MalfunctionSep 15, 2026No Apparent Adverse Event

  Medtronic received information regarding a loaner device return with no alleged product deficiencies. No patient involvement in this event. Additional information was received stating that bearing detachment was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770768 ↗
• MalfunctionSep 4, 2026No Apparent Adverse Event

  Medtronic received information regarding a planned maintenance with no alleged product deficiency. There was no patient involvement. Additional information was received stating bearing detachment was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50609348 ↗
• MalfunctionAug 8, 2026Difficult to Insert

  It was reported that during preparing for use attachments was not working. It was reported there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50187250 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. 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 25715955 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS DEFECTIVE. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED UPON EVALUATION THAT THE DISTAL BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714975 ↗
• MalfunctionJul 3, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT DRILL WAS VIBRATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25704164 ↗
• MalfunctionJul 3, 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 IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703338 ↗
• MalfunctionJul 3, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF BROKEN RING. 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 25701281 ↗
• MalfunctionJul 2, 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 IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696289 ↗
• MalfunctionJul 2, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT RETAIN. 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 25687206 ↗
• 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 BROKEN BEARINGS WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677462 ↗
• MalfunctionJul 1, 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 25676438 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE AT THE TIME OF INTAKE. NO PATIENT IMPACT REPORTED.  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25676048 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25669196 ↗
• MalfunctionJun 25, 2026Loss of Power

  IT WAS REPORTED THAT PRIOR TO USE THE ATTACHMENT WAS NOT WORKING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING BEARING DETACHED WAS FOUND DURING EVALUATION MADE IT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617733 ↗
• MalfunctionJun 19, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE SEIZED. 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 25559033 ↗
• MalfunctionJun 19, 2026Vibration; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE ATTACHMENT DRILL, SWINGS ENORMOUSLY. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25557121 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING IS FALLING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404805 ↗
• MalfunctionMay 6, 2026Loss of Power

  IT WAS REPORTED THAT AN ATTACHMENT WAS NOT WORKING, IT WAS OBSERVED PRE-OPERATIVELY WHILE PREPARING FOR USE. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093087 ↗
• MalfunctionApr 20, 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 IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24922715 ↗
• MalfunctionApr 20, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD DISSATISFACTION WITH THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER PRODUCT EVALUATION THAT BEARING WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921564 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING AND COULD NOT ATTACH PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED AFTER EVALUATION WAS DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907814 ↗
• MalfunctionApr 14, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT A SERVICE REQUEST WAS CREATED FOR THE ATTACHMENT AND IT WAS DESCRIBED AS DEFECTIVE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24868269 ↗
• MalfunctionApr 13, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOESN'T HOLD THE TOOL. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854480 ↗