HydroFill Helical 100615HFIL-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777024404), received between Apr 23, 2021 and Apr 22, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN WAS TREATING AN ANEURYSM ON THE RIGHT MEDIA BIFURCATION. SHE WANTED TO COIL THE ANEURYSM USING A REMODELING TECHNIQUE. AFTER PLACING SEVERAL COILS, A HYDROFILL WAS CHOSEN. WHILE REPOSITIONING THE COIL PREMATURELY DETACHED. THE COIL WAS EXCHANGED AND THE EXAMINATION CONTINUED. AFTER SUCCESSFUL COILING THE IMPLANTATION OF A STENT WAS PLANNED AND CHOSEN. THE STENT PREMATURELY DETACHED IN THE MICROCATHETER. THE STENT WAS EXCHANGED AND THE EXAMINATION CONTINUED WITH GOOD RESULT. THE PATIENT IS DOING WELL. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887227 ↗
• InjuryMay 8, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN PUT THE COÏL IN ANEURYSM (ACA). IT WAS THE SECOND COÏL. THE PHYSICIAN DECIDED TO REPOSITION THIS COÏL AFTER COMPLETE DEPLOYMENT. WHEN IT WAS RETRIEVED, THE COÏL BROKE AND AFTER SEVERAL ATTEMPTS TO RETRIEVE ALL OF THE COÏL, A HALF PART OF COÏL WAS LEFT IN THE VESSEL, CAROTID ARTERY. THE PHYSICIAN WAS THEN OBLIGED TO PUT TWO CAROTID STENTS INSIDE THE VESSEL TO MAINTAIN THE BROKEN COÏL. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT, "WHEN THE COIL WAS DETACHED USING THE DETACHMENT SYSTEM, THE SECTION WAS COMPLETED, BUT THE PUSHER CATHETER REMAINED ATTACHED. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE COIL AND PUSHER WITH RETRIEVER STENTS, IT ONLY ¿DESCENDED¿ TO THE LEVEL OF THE COMMON CAROTID ARTERY. IT WAS NECESSARY TO STENT THE CAROTID ARTERY WITH 2 CAROTID STENTS IN ORDER TO PLATE THE PUSHER AND STENT ALONG THE CAROTID WALL."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274207 ↗
• InjuryApr 23, 2021Difficult to Remove; Stretched; Detachment of Device or Device Component; Difficult to Remove; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL STRETCHED AND PREMATURELY DETACHED IN THE VESSEL. THE COIL WAS RETRIEVED WITH AN ENDOVASCULAR SNARE. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712773 ↗