MIDAS REX MR8 MR8-AVS07 (UDI 00763000441357)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000441357), received between Sep 5, 2024 and Sep 29, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Vibration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929503 ↗
• MalfunctionSep 28, 2026Naturally Worn

  It was reported that during pre-operative preparation for use, the bearings were running rough in the device. There was no patient impact in this event. Additional information received on evaluation that bearings were misaligned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910839 ↗
• MalfunctionJul 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: Insufficient Information

  MAUDE report 25697314 ↗
• MalfunctionJul 2, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE HAS BROKEN TIP. 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 25697176 ↗
• MalfunctionJul 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: Insufficient Information

  MAUDE report 25696469 ↗
• 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 25691860 ↗
• MalfunctionJul 2, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO SPECIFIED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BEARING WAS FOUND DETACHED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691643 ↗
• MalfunctionJul 2, 2026Loss of Power

  IT WAS REPORTED THAT THE DEVICE WAS FACING LOW SPEED /TORQUE/POWER. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687270 ↗
• 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 25676350 ↗
• 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 25667305 ↗
• MalfunctionJun 21, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE THE DISTAL BEARINGS WERE OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING THAT NO BEARINGS WERE FOUND AT THE DISTAL TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25571770 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HEATING UP INTRAOPERATIVELY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469156 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT BEARING WAS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441298 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE BEARINGS FELL OUT OF THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25440790 ↗
• MalfunctionJun 7, 2026Corroded

  IT WAS REPORTED THAT THE DEVICE WITH CORROSION. 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 25421904 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT HAS A MISSING PIECE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25358057 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BEARING IS DETACHED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268649 ↗
• MalfunctionApr 28, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DIFFICULT TO TURN THE RING OF THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013747 ↗
• MalfunctionApr 27, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DIFFICULT TO TURN THE RING. IT WAS REPORTED THAT 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 24997303 ↗
• MalfunctionApr 24, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975848 ↗
• MalfunctionApr 16, 2026Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT WAS NO LONGER RUNNING ON THE ENGINE. AT THE TIME OF REPORT, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE BEARINGS WERE DETACHED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898931 ↗
• MalfunctionApr 9, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. AT THE TIME OF REPORT, THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834070 ↗
• MalfunctionMar 30, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE RING DOES NOT ROTATE PRIOR TO USE. IT WAS 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 24727066 ↗
• MalfunctionMar 30, 2026Loss of Power; Naturally Worn

  IT IS REPORTED THAT THE DEVICE IS NOT SPINNING . IT IS REPORTED THAT THERE IS 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 24725483 ↗
• MalfunctionMar 24, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24672889 ↗