MIDAS REX MR8 MR8-T12BA30DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000514051), received between Nov 6, 2025 and Jan 28, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Fracture; Difficult to Remove; Naturally Worn

  IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH A PITUITARY TUMOR AND DURING THE ENDOSCOPIC TRANSSPHENOIDAL RESECTION PROCEDURE, THE MICRO BURR HEAD MR8-T12BA30D WAS FRACTURED. WHEN USING THIS CONSUMABLE THE POWER SYSTEM DRILL BIT BECAME STUCK AND COULD NOT OPERATE CAUSING THE HANDPIECE BEARING TO BREAK AND MAKING IT UNUSABLE. THIS AFFECTED THE PROGRESS OF THE SURGERY, BUT THE DOCTOR PROMPTLY REPLACED THE CONSUMABLE AND COMPLETED THE PROCEDURE. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. IT WAS ALSO REPORTED THAT THERE WAS NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS FIVE MINUTES DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ADDITIONAL INFORMATION WAS RECEIVED STATING THE THAT THERE WAS NO PATIENT OR STAFF IMPACT, EIGHT MINUTES DELAY IN PROCEDURE AND NO I NTERVENTION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198380 ↗
• MalfunctionNov 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC TRANSNASAL PITUITARY TUMOR SURGERY, THE DRILL BIT BROKE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484747 ↗