FlareHawk CMP-00897Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004721616), received between Apr 7, 2025 and Apr 7, 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. 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.

• MalfunctionApr 7, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, IT WAS REPORTED THAT A DOCTOR HAD INITIALLY DETERMINED THAT A FLAREHAWK SHIM AND SHELL WERE PROPERLY LOCKED. THE DOCTOR INDICATED HE HEARD A LOUD POP WHEN DEPLOYING THE SHIM INTO THE SHELL. HE USED THE LOCK GAUGE, AND THE GUIDE PROTRUDED OUT THE BACK OF THE LOCK GAUGE. HE BELIEVED THE IMPLANT WAS LOCKED BASED UPON THE READING. WHEN HE REMOVED THE GUIDE PIN THE THREADS OF THE CORE (PART OF THE SHELL) WERE INSIDE THE GUIDE PIN. UPON SUBSEQUENT REVIEW OF THE PATIENT X-RAYS, IT IS BELIEVED THAT THE SHIM AND SHELL ARE NOT LOCKED AS INTENDED. THERE WAS A DELAY OF 10 MINUTES. THE PATIENT IS DOING WELL AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785650 ↗