Midas Rex MR8 MR8-AS14 (UDI 00643169912281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169912281), received between Oct 13, 2021 and Sep 25, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 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 bearings misaligned was found during evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894025 ↗
• MalfunctionSep 7, 2026Device Displays Incorrect Message

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50653673 ↗
• MalfunctionJul 3, 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 BEARING DETACHMENT WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701324 ↗
• MalfunctionJul 2, 2026Naturally Worn

  IT WAS REPORTED THAT DURING PRE-OP THE PIECE BROKEN OFF INSIDE. AT THE TIME OF REPORT NO PATIENT OR STAFF IMPACT IS BEEN OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687069 ↗
• MalfunctionJun 22, 2026Difficult to Remove; Vibration

  IT WAS REPORTED THAT DURING PREOP, DRILL WOBBLES. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE DETACHED BEARINGS INSIDE THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573050 ↗
• MalfunctionJun 19, 2026Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556827 ↗
• MalfunctionJun 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE O-RING WAS LOOSE ON THE ATTACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521737 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE ATTACHMENT HAS A LOOSE O-RING. 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 25517859 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT IN PRIOR-OP THE DEVICE WAS HEATING  UP WHILE IN USE.  IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE BEARING FALLOUT WAS FOUND DURING EVALUATION MADE IT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514168 ↗
• MalfunctionJun 15, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING THE TESTING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING CHIPPED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500699 ↗
• MalfunctionJun 15, 2026Vibration

  IT WAS REPORTED THAT THE ATTACHMENT VIBRATED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498096 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT SOMETHING WAS LOOSE INSIDE THE ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490991 ↗
• MalfunctionJun 12, 2026Overheating of Device

  IT WAS REPORTED THAT ATTACHMENT GETS HOT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25483527 ↗
• MalfunctionJun 11, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING PRIOR TO USE. IT WAS REPORTED THAT 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 25472341 ↗
• MalfunctionJun 11, 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 25468709 ↗
• MalfunctionJun 9, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WITH HEATING UP. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25445990 ↗
• MalfunctionJun 8, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING CHIPPED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425876 ↗
• MalfunctionJun 6, 2026Overheating of Device; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, THE ATTACHMENT WAS CHATTERING AND OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418598 ↗
• MalfunctionJun 4, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25387171 ↗
• MalfunctionJun 1, 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 INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS WERE DETACHED FOUND IN ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349193 ↗
• MalfunctionJun 1, 2026Noise, Audible

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT MAKING WEIRD NOISE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25346618 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE OF BEARING DETACHMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330885 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED 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 25274906 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT, BEARING LOOSE. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268898 ↗
• MalfunctionMay 6, 2026Naturally Worn

  IT WAS REPORTED THAT THE BEARINGS WERE DAMAGED IN THE ATTACHMENT PRIOR TO ITS USE. AT THE TIME OF THE REPORT, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092330 ↗