Midas Rex MR8 MR8-AD03 (UDI 00643169912717)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169912717), received between Jan 16, 2022 and Jul 1, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 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 ON THE PERFORATOR OUTPUT SUB-ASSEMBLY ARE DETACHED WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674544 ↗
• MalfunctionJun 18, 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 THE BEARING THAT WAS MISSED WAS FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542144 ↗
• MalfunctionJun 15, 2026Corroded; Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT DID NOT WORK PROPERLY AND RUST WAS OBSERVED COMING OUT OF THE DEVICE WHEN IT WAS BLOWN. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505673 ↗
• MalfunctionJun 10, 2026Detachment of Device or Device Component; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE ATTACHMENT HAD BEARING DETACHMENT AND LOSE BLACK PARTICLES. NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25454376 ↗
• MalfunctionMay 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300485 ↗
• MalfunctionMay 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ATTACHMENT, BEARING DETACHMENT. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267957 ↗
• MalfunctionApr 8, 2026Loss of Power

  IT WAS REPORTED THAT ATTACHMENT WAS NOT SPINNING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24812728 ↗
• MalfunctionJun 30, 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 22355920 ↗
• MalfunctionJun 24, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320959 ↗
• MalfunctionApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF 3 WASHERS DETACHED FROM THE PART THAT CONNECTS TO THE MOTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776542 ↗
• MalfunctionDec 4, 2024Loss of Power; Detachment of Device or Device Component; Loss of Power; Detachment of Device or Device Component

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOOSE PIECE AND DOES NOT MOVE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845064 ↗
• MalfunctionNov 14, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683266 ↗
• MalfunctionNov 4, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND LOW POWER. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597664 ↗
• MalfunctionSep 20, 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 THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264829 ↗
• InjuryMar 28, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT WAS OPERATED FOR RESECTION OF MENINGIOMA OF OLFACTORY TRACT (TUMOR REMOVAL) PROCEDURE. POST OPERATION, A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND THE RAYS WERE FOUND SCATTERING DUE TO A FOREIGN BODY (SPHERE METAL BALL) OF 1 MILLI METER IN SUBDURAL LOCATION. IT WAS REPORTED THAT THE METAL BALL GOT RELEASED FROM THE DRILL IN THE OPERATION PROCEDURE. THE HEALTH CARE PROFESSIONAL PERFORMED A SECOND SURGERY TO RETRIEVE THE BALL. AS PART OF SECOND SURGERY, THE PREVIOUS RIGHT FRONTO-PTERIONA WOUND WAS REOPENED AND A SMALL PART OF DURAL WAS OPENED. THE SPHERE METAL BALL WAS LYING BELOW CEREBRAL PERCHYMA WHICH WAS THEN REMOVED. IT WAS REPORTED THAT THERE WAS A DELAY IN SURGERY FOR 120 MINUTES AND THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. IT WAS ALSO REPORTED THAT ALL THE ATTACHMENTS WERE FINE WITHOUT SIGNALS OF RUPTURES OR BREAKAGES AND THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18994669 ↗
• InjuryJan 16, 2022Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING DEEP BRAIN STIMULATOR PLACEMENT, THE MIDAS REX MR8 PNEUMATIC DRILL WITH A MR8-AD03 PERFORATOR DRIVER AND DISPOSABLE CODMAN PERFORATOR FAILED TO STOP SPINNING AND DRILLED INTO THE PATIENT'S BRAIN. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO STAFF IMPACT AND THE PATIENT WAS INJURED WITH EXCESSIVE BLEEDING, WHICH WOULD BE THE CASE IN NORMAL OPERATION. THE CASE WAS DELAYED FOR ABOUT AN HOUR AS THE SURGEONS GOT THE BLEEDING UNDER CONTROL. THE PATIENT HAS BEEN DISCHARGED AND WAS OKAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13262612 ↗