FlareHawk CMP-00666Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004721562), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 25, 2025Activation Problem; Activation Problem

  ON 2/25/2025, IT WAS REPORTED TO ACCELUS THAT THE REP RAN INTO AN ISSUE WHILE DEPLOYING A CAGE IN DR. (B)(6) INITIAL TLIF CASE ON (B)(6) 2025. THE REP FOLLOWED SURGICAL TECHNIQUE AND WHEN USING THE EXPANDABLE SHAVER, THEY GOT AN 11MM HEIGHT SO THEY BUILT A 26X11X11 0 DEGREE CAGE. WHILE DEPLOYING THE CAGE, THEY HEARD THE CLICK AS USUAL AND AN IMAGE AFTERWARDS WAS TAKEN SHOWING THE SHIM WAS NOT LOCKED INTO THE SHELL. THE GUIDE PIN MUST HAVE SNAPPED INSTEAD. IT WAS REPORTED THERE WAS NO IMPACT TO PATIENT AND NO DELAY TO THE PROCEDURE. THE SURGEON LEFT THE SHIM IN THE SHELL, PLACED SCREWS AND RODS AND FINISHED THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692293 ↗