Midas Rex MR8 MR8-AF02R (UDI 00643169912427)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169912427), received between Mar 20, 2023 and Sep 29, 2026 — classified as 32 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Loss of Power

  It was reported that the device was not rotating while preparing for use. There was no patient impact. Additional information received as bearings misaligned found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929486 ↗
• MalfunctionSep 28, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921231 ↗
• MalfunctionSep 28, 2026Difficult to Insert

  It was reported that during pre-operative preparation, the device was not locking. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913675 ↗
• MalfunctionSep 28, 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 bearing misaligned was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911585 ↗
• MalfunctionSep 23, 2026Loss of Power

  It was reported that the device doesn't work. 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 50864724 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component; No Apparent Adverse Event

  It was reported that the attachment was defective. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864153 ↗
• MalfunctionJul 6, 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 KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25713642 ↗
• MalfunctionJul 2, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT HAD INSERTION DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693539 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD A DISSATISFACTION WITH THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693253 ↗
• MalfunctionJul 1, 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 25681469 ↗
• MalfunctionJul 1, 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 25676819 ↗
• 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 KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: Insufficient Information

  MAUDE report 25666333 ↗
• MalfunctionJun 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT IS NOT WORKING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662300 ↗
• MalfunctionJun 24, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. 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 25612243 ↗
• MalfunctionJun 11, 2026Difficult to Insert

  IT WAS REPORTED THAT THE BURR DOES NOT LOCK IN THE ATTACHMENT. AT THE TIME OF REPORT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474269 ↗
• MalfunctionJun 5, 2026Loss of Power

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406073 ↗
• MalfunctionMay 15, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. DURING SCHEDULED PREVENTIVE MAINTENANCE, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER PRODUCT EVALUATION THAT BEARING FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180095 ↗
• MalfunctionMay 12, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147505 ↗
• MalfunctionApr 28, 2026Naturally Worn

  IT WAS REPORTED THAT ATTACHMENT WAS DAMAGED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013587 ↗
• MalfunctionApr 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927274 ↗
• MalfunctionApr 16, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ATTACHMENT WITH NO REPORTED ALLEGATION. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24894937 ↗
• MalfunctionApr 8, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS FROZEN. 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 24813045 ↗
• MalfunctionApr 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT REPAIR REQUEST WAS RAISED WITH NO ALLEGED PRODUCT DEFICIENCIES. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787309 ↗
• MalfunctionDec 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF NOT A COMPLAINT AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 23874934 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF PROBLEM NOT REPORTED. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT ON EVALUATION DUE TO THE BEARING DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085640 ↗