UltraClear AS-BM-00055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850039149047), received between Jun 18, 2025 and Aug 5, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionAug 5, 2026Failure to Deliver Energy; Radiation Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148444 ↗
• InjuryJun 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN 80-YEAR-OLD PATIENT WAS TREATED USING THE ULTRACLEAR SYSTEM ON THE LEGS. THE TREATMENT WAS SUPERFICIAL AND PRODUCED SIGNIFICANTLY MORE TISSUE DAMAGE THAN EXPECTED BY THE DOCTOR. BOTH LEGS HAD POOR HEALING ON THE LOWER LEG. INVESTIGATION REVEALED THE PATIENT HAD INFLAMMATION IN BOTH LEGS PRIOR TO TREATMENT. ULTRACLEAR TREATMENT ON THE LEGS TAKES MORE TIME TO HEAL THAN OTHER AREAS OF THE BODY IN THE BEST CONDITIONS. THE PATIENTS PRE-EXISTING INFLAMMATION SHOULD NEVER HAVE BEEN TREATED WITH THE ULTRACLEAR ESPECIALLY AT THE PATIENT'S ADVANCED AGE. THIS WAS AN INAPPROPRIATE CANDIDATE FOR THIS TREATMENT.

  Patient problems: Radiation Burn

  MAUDE report 22286706 ↗