Midas Rex MR8 MR8-AVS14 (UDI 00643169912632)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169912632), received between Aug 25, 2025 and Sep 29, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 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 bearings misaligned, laser markings faded, and o-ring worn  was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930541 ↗
• MalfunctionSep 27, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50910282 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE OF AN ATTACHMENT, IT BECAME OVERHEATED. IT WAS FURTHER REPORTED THAT THERE WAS NO IMPACT ON THE PATIENT OR STAFF. ADDITIONAL INFORMATION RECEIVED AS BEARINGS MISALIGNED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699677 ↗
• MalfunctionJul 2, 2026Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE OF AN ATTACHMENT, IT BECAME OVERHEATED. IT WAS FURTHER REPORTED THAT THERE WAS NO IMPACT ON THE PATIENT OR STAFF. ADDITIONAL INFORMATION RECEIVED AS BEARINGS MISALIGNED FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699626 ↗
• MalfunctionJun 26, 2026Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633610 ↗
• MalfunctionJun 19, 2026Difficult to Insert

  IT WAS REPORTED THAT WHILE SERVICING, THE TOOLS WERE NOT LOCKING IN THE ATTACHMENT. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565981 ↗
• MalfunctionJun 16, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514526 ↗
• MalfunctionJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT STUCK AND WILL NOT EXTEND TO ATTACH. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE DETACHED BEARINGS INSIDE THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427303 ↗
• MalfunctionJun 5, 2026Overheating of Device; Vibration

  IT WAS REPORTED THAT THE DEVICE IS RATTLING AND HEATING UP DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403975 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PIECE FELL OUT FROM INSIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DISTAL BEARING WAS CHIPPED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361793 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT BEARINGS FELL OUT. AT THE TIME OF REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25296341 ↗
• MalfunctionMay 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE TEMPERATURE WAS INCREASE PRIOR TO USE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARING WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270133 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268526 ↗
• InjuryAug 25, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT POTENTIAL SMALL BURN TO THE PATIENTS SKIN.

  Patient problems: Burn(s)

  MAUDE report 22882085 ↗