Midas Rex MR8 MR8-AS09 (UDI 00643169912274)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169912274), received between Sep 9, 2024 and Jul 1, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT HAD DIFFICULTY INSERTING A TOOL OR BLADE IN A PRE-OPERATIVE CONTEXT. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678328 ↗
• MalfunctionJun 29, 2026Difficult to Insert

  IT WAS REPORTED THAT THE ATTACHMENT WAS NOT WORKING PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650008 ↗
• MalfunctionJun 24, 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 BEARING DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605997 ↗
• MalfunctionJun 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER USE, THE ATTACHMENT BEARING WAS FOUND LOOSE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25575448 ↗
• MalfunctionJun 17, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BEARING WAS DAMAGED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530482 ↗
• MalfunctionJun 17, 2026Overheating of Device

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, THE ATTACHMENT WAS ALLEGED TO HAVE EXPERIENCED OVERHEATING, WAS RUNNING HOT, AND WAS HEATING UP.IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530154 ↗
• MalfunctionJun 17, 2026Overheating of Device

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE, THE ATTACHMENT  EXHIBITED OVERHEATING, WAS RUNNING HOT, AND WAS HEATING UP. IT WAS R EPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530050 ↗
• 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 25471772 ↗
• MalfunctionJun 10, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED STATING DAMAGE TO THE BEARING INSIDE THE ATTACHMENT WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455711 ↗
• MalfunctionJun 5, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BALL BEARING BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARING BROKEN WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407203 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT WAS BEARINGS FELL OFF. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405126 ↗
• MalfunctionMay 29, 2026Naturally Worn

  IT WAS REPORTED THAT THE DEVICE WITH THE REPORT OF BEARING PROBLEM. 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 25331316 ↗
• MalfunctionApr 27, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT DUE TO THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING LOOSE BEARINGS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24995356 ↗
• MalfunctionApr 27, 2026Difficult to Insert

  IT WAS REPORTED THAT PRIOR TO USE, THE BURR DID NOT FIT IN THE ATTACHMENT. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994773 ↗
• MalfunctionApr 23, 2026Naturally Worn

  IT WAS REPORTED THAT PRIOR TO USE BEARING PROBLEM WAS OBSERVED. AT THE TIME OF REPORT THERE WAS NO PATIENT OR STAFF IMPACT. ADDITIONAL INFORMATION RECEIVED THAT BEARINGS WERE DETACHED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968607 ↗
• MalfunctionApr 16, 2026Naturally Worn

  IT WAS REPORTED THAT THE ATTACHMENT WAS BROKEN. 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 24892780 ↗
• MalfunctionApr 13, 2026Naturally Worn

  IT WAS REPORTED THAT THE ONE ATTACHMENT WAS NOT SPINNING AND ANOTHER ATTACHMENT HAS BAD BEARINGS. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BEARINGS MISALIGNED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857251 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTACHMENT BALL BEARING WAS FELL OUT/ MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671400 ↗
• MalfunctionMar 18, 2026Naturally Worn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625264 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CRANIOTOMY, THE RING IS DISLODGED AND RETAIN INSIDE THE ATTACHMENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. OTHER ATTACHMENTS AND THE HANDPIECE WERE TESTED AFTER THE CASE AND FUNCTIONED NORMALLY. NO SYMPTOMS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23766945 ↗
• MalfunctionApr 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866065 ↗
• MalfunctionSep 23, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOT WORKING WELL. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278352 ↗
• MalfunctionSep 9, 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 20169810 ↗