Midas Rex MR8 MR8-AA12 (UDI 00643169912366)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169912366), received between Sep 23, 2024 and Sep 10, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. No patient impact or c omplications have been reported as a result of this event. Additional information received stating that bearings were detached during evaluation. Additional information received that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713450 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707349 ↗
• MalfunctionJul 3, 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 THAT WAS DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702949 ↗
• MalfunctionJul 2, 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 25695761 ↗
• 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 25665390 ↗
• MalfunctionJun 24, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605660 ↗
• MalfunctionMay 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT CUSTOMER HAD A GENERAL DISSATISFACTION ON THE DEVICE. THERE WAS NO IMPACT TO THE PATIENT IN THIS EVENT AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED AFTER EVALUATION AS DETACHED BEARING AND LASER MARKINGS FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297678 ↗
• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT HEATS UP PORIOR TO OPERATION, AT THE TIME OF THE REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287907 ↗
• MalfunctionSep 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF UNSPECIFIED MALFUNCTION. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22988964 ↗
• MalfunctionJun 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22191753 ↗
• MalfunctionMay 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO ALLEGED ISSUE REPORTED. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS. ON FOLLOW-UP IT WAS REPORTED THAT THERE WERE NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078811 ↗
• MalfunctionApr 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 21753737 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT A COMPLAINT. NO PATIENT IMPACT REPORTED. THE EVENT ESCALATED TO PRODUCT EVENT AS EVALUATION CONFIRMED DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742118 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHED BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276540 ↗