FlareHawk FHPACS0025TTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004728158), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 18, 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.

• MalfunctionFeb 20, 2025Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427198 ↗