Midas Rex MR8 MR8-AA07 (UDI 00643169912380)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169912380), received between Aug 28, 2024 and Aug 17, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Difficult to Insert

  It was reported that the attachment with the report of loss of power. 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 50270084 ↗
• MalfunctionJul 6, 2026Naturally Worn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ATTACHMENT HAD FAILED BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25713682 ↗
• MalfunctionJul 3, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ATTACHMENT HAD BLADES NOT LOCKING . NO KNOWN PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25700955 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. 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 25691931 ↗
• MalfunctionJun 23, 2026Difficult to Insert

  IT WAS REPORTED THAT DEVICE HAD A ISSUE OF WON'T BE FIXED ON THE MOTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591233 ↗
• MalfunctionJun 19, 2026Naturally Worn

  IT WAS REPORTED THAT DURING USE, THE ATTACHMENT BEARING HAD FAILED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25559478 ↗
• MalfunctionJun 18, 2026Naturally Worn

  IT WAS REPORTED DURING USE THAT THE ANGLED ATTACHMENT BEARING FAILED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION STATING THAT BEARING FALL OUT AT TUBE DISTAL DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542891 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF OVERHEATING. 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 25481719 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE BALL BEARING WAS FELL OUT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441037 ↗
• MalfunctionJun 8, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS ALSO REPORTED THAT 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 25432278 ↗
• MalfunctionApr 30, 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 SEIZED DISTAL BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25042592 ↗
• MalfunctionApr 24, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD DISSATISFACTION WITH THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980629 ↗
• MalfunctionApr 3, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773020 ↗
• MalfunctionApr 3, 2026Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE TIP OF THE ATTACHMENT WAS BURNT. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772882 ↗
• MalfunctionOct 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DOESN'T WORK. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23365580 ↗
• MalfunctionJun 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NO INITIAL ALLEGATION. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129468 ↗
• MalfunctionMar 10, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562006 ↗
• MalfunctionDec 11, 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 20900203 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BEARING DETACHMENT. IT WAS REPORTED 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 20085651 ↗