PHASOR 4.50KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B775450K0), received between Apr 18, 2025 and Apr 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Component Misassembled; Component Misassembled

  1. SWITCH ACTIVATION OF LOT: 241030450 OF PHASOR HEALTH 4.50K FIXED DISPOSABLE CRANIAL ACCESS DRILLS MAY CAUSE THEM TO OPERATE IN THE OPPOSITE DIRECTION THAN INTENDED. 2. IF THIS OCCURS, ANOTHER DRILL WILL BE NECESSARY, POSSIBLY DELAYING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866668 ↗