HydroFill Helical 100306HFIL-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023254), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Unraveled Material” (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.

• InjuryJan 6, 2022Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING TREATMENT OF A RECURRENT ACOM ANEURYSM VIA STENT ASSISTED COILING, THE COIL DID NOT DETACH WITH MULTIPLE ATTEMPTS. IT WAS DECIDED TO TRY AND REMOVE THE COIL FROM THE ANEURYSM BY WITHDRAWING IT INTO THE HW DUO. AFTER WITHDRAWING APPROXIMATELY 2CM OF COIL INTO THE MICROCATHETER THE COIL BECAME JAMMED AND COULD NOT BE WITHDRAWN FURTHER. THE MICROCATHETER WAS THEN ATTEMPTED TO BE WITHDRAWN FROM THE SAC ALONG WITH THE COIL. UPON WITHDRAWAL OF THE MICROCATHETER THE COIL WAS ENTANGLED WITHIN THE COIL MASS AND WAS UNABLE TO BE CLEANLY REMOVED. RETRACTION OF THE COIL PUSHER RESULTED IN PARTIAL SEPARATION OF THE PUSHER AND APPEARED TO DELAMINATE THE COIL AND A SNARE WAS EVENTUALLY USED TO RETRIEVE AS MUCH OF THE COIL AS POSSIBLE. A SMALL REMAINING FILAMENT TAIL REMAINED FROM THE ANEURYSM TO THE CAVERNOUS SECTION OF THE LEFT ICA AND THIS WAS STABILIZED AND TRAPPED AGAINST THE WALL WITH PLACEMENT OF A STENT. THE PATIENT RECOVERED TO BE DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173709 ↗