MIDAS REX MR8 MR8-AVA07 (UDI 00763000441227)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000441227), received between Aug 21, 2024 and Jul 2, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25695093 ↗
• 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 25692830 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT DOES NOT WORK 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 25690182 ↗
• MalfunctionJun 16, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25515688 ↗
• MalfunctionJun 15, 2026Corroded; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501373 ↗
• MalfunctionJun 15, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499740 ↗
• MalfunctionJun 15, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498557 ↗
• MalfunctionJun 9, 2026Vibration

  IT WAS REPORTED THAT ATTACHMENT WOBBLES WHEN IT ROTATES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439138 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BEARING WERE FELL OUT DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DISTAL BEARING WAS DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328272 ↗
• MalfunctionApr 21, 2026Loss of Power

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE GOT FROZEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934945 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF DEVICE BROKE AND HANDPIECE PRACTICALLY DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT . ADDITIONAL INFORMATION WAS RECEIVED STATED THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923947 ↗
• MalfunctionApr 17, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT COULD NOT RETAIN TOOL. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912492 ↗
• MalfunctionMar 30, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT A ATTACHMENT WAS REQUESTED FOR EXCHANGE AFTER IT WAS OBSERVED TO NOT WORK PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732202 ↗
• MalfunctionMar 30, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730571 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT PRIOR TO EXCHANGE, PARTS DETACHED AND ROUGH RUNS WERE OBSERVED WITH THE DEVICE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24725697 ↗
• MalfunctionMar 24, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE EXHIBITED OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680922 ↗
• MalfunctionNov 27, 2024Naturally Worn; Naturally Worn

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF WORN. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793424 ↗
• MalfunctionOct 25, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531271 ↗
• MalfunctionSep 25, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298382 ↗
• MalfunctionSep 19, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.  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 20255114 ↗
• MalfunctionSep 3, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127538 ↗
• MalfunctionAug 21, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018954 ↗