Midas Rex MR8 MR8-AVA15 (UDI 00643169912670)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169912670), received between Aug 19, 2024 and Sep 29, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026No Apparent Adverse Event

  It was reported that the attachment is defective. It was reported that there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927066 ↗
• MalfunctionSep 11, 2026Detachment of Device or Device Component

  It was reported that the attachment was returned for PM. There was no patient involved. Additional information received that the bearing was detached found during an evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725955 ↗
• MalfunctionSep 1, 2026Vibration

  It was reported that the milling head has too much play. 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 50536558 ↗
• MalfunctionAug 26, 2026No Apparent Adverse Event

  It was reported that device was not functioning. At the time of report there was no patient impact. Additional information received that the event was pre-operative and also, detached bearings were found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50444077 ↗
• MalfunctionJul 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER HAD A DISSATISFACTION WITH THE PRODUCT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RE CEIVED STATING BEARING DETACHMENT WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25715040 ↗
• MalfunctionJul 6, 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 25714658 ↗
• MalfunctionJul 3, 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 25704986 ↗
• MalfunctionJul 2, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT 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 25692988 ↗
• MalfunctionJul 2, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT HAD BEARING DEFECTIVE, MILLING ATTACHMENT LOOSE DESPITE LOCKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688357 ↗
• MalfunctionJul 2, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT HAD ASSEMBLY DIFFICULTY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688184 ↗
• MalfunctionJul 2, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF WORN. 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 25686991 ↗
• 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 25678365 ↗
• MalfunctionJul 1, 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 25676254 ↗
• MalfunctionJul 1, 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 25676126 ↗
• MalfunctionJul 1, 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 25675945 ↗
• MalfunctionJun 30, 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 25662947 ↗
• 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 OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662785 ↗
• MalfunctionJun 23, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. AT THE TIME OF REPORT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593976 ↗
• MalfunctionJun 17, 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 25529410 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520027 ↗
• MalfunctionJun 15, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN . AT THE TIME OF REPORT NO PATIENT IMPACT IS BEEN OBSERVED . ADDITIONAL INFORMATION RECEIVED THAT BEARING WERE DETACHED DURING THE EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25501261 ↗
• MalfunctionMay 31, 2026Naturally Worn

  IT WAS REPORTED THAT DEVICE IS DEFECTIVE. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344928 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COMPONENT WAS DETACHED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273729 ↗
• MalfunctionMay 25, 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 DETACHED BEARINGS WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25269024 ↗
• MalfunctionMay 15, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180435 ↗