Midas Rex MR8 MR8-AVS07 (UDI 00643169912571)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169912571), received between Sep 23, 2024 and Jul 6, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25714443 ↗
• MalfunctionJul 6, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE SEIZED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713468 ↗
• MalfunctionJul 4, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT OVERHEATS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709709 ↗
• MalfunctionJul 2, 2026Difficult to Insert

  IT WAS REPORTED THAT THE TOOLS / BLADES WERE NOT LOCKING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION STATED THAT BEARING DETACHED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688908 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677019 ↗
• MalfunctionJun 30, 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 25664150 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT DURING MAINTENANCE, ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498361 ↗
• MalfunctionJun 11, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467728 ↗
• MalfunctionJun 5, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF VIBRATION.  IT WAS REPORTED THAT THERE WAS NO PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403819 ↗
• MalfunctionApr 28, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOESN'T HOLD THE TOOL PROPERLY. AT THE TIME OF REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017997 ↗
• MalfunctionApr 22, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DID NOT LOCK CUTTER TOOL PROPERLY. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24951876 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856910 ↗
• MalfunctionApr 6, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT DOESN'T HOLD THE WICK DURING A USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED DISTAL BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787257 ↗
• MalfunctionApr 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT NOT RETAIN THE TOOL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754195 ↗
• MalfunctionFeb 26, 2026Corroded

  IT WAS REPORTED THAT THE ATTACHMENT WAS CORRODED. IT WAS REPORTED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING MISALIGNMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453942 ↗
• MalfunctionNov 29, 2025Overheating of Device; Naturally Worn; Noise, Audible; Overheating of Device; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT FRONT BEARINGS WERE DAMAGED, NOISY, AND OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675689 ↗
• MalfunctionNov 13, 2025Overheating of Device; Naturally Worn; Noise, Audible; Overheating of Device; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE ATTACHMENT FRONT BEARINGS WERE DAMAGED, NOISY, AND OVERHEATING. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547267 ↗
• MalfunctionJan 30, 2025Detachment 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. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274601 ↗
• MalfunctionSep 23, 2024Vibration; Vibration

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF VIBRATION. IT WAS REPORTED THAT 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 20277655 ↗