Midas Rex MR8 MR8-AVA12 (UDI 00643169912663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169912663), received between Mar 17, 2025 and Jul 2, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691533 ↗
• MalfunctionJul 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT HAS GENERAL DISSATISFACTION. 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 25676691 ↗
• MalfunctionJun 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. 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 25349182 ↗
• MalfunctionApr 14, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT'S TIP IS WORN END BURNED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871014 ↗
• MalfunctionApr 13, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE THE CUSTOMER HAD DISSATISFACTION WITH THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATED THAT DISTAL BEARINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853785 ↗
• MalfunctionApr 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762169 ↗
• MalfunctionMar 31, 2026Overheating of Device; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT'S TIP WAS WORN AND BURNED. THERE WAS NO PATIENT/STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740455 ↗
• MalfunctionMar 17, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS. ON FOLLOW-UP NO FURTHER INFORMATION WAS PROVIDED ON PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21616359 ↗