HydroFill Helical 100510HFIL-V-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023292), received between Feb 14, 2019 and Nov 15, 2024 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Premature Separation; Premature Separation

  AS REPORTED: COILING OF M1 ANEURYSM. ATTEMPTED TO ADVANCE HYDROFILL COIL THROUGH A MICROCATHETER. WHILE ADVANCING THE COIL, IT PREMATURELY DETACHED ¿ PART IN CATHETER/PART IN THE ANEURYSM. THERE WAS ENOUGH COIL STILL IN THE MICROCATHETER, THAT WHEN THE DR PULLED THE CATHETER OUT, THE COIL CAME WITH IT. PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700853 ↗
• MalfunctionJun 29, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED TO TREAT A PATIENT WITH A PRE-RUPTURED ANEURYSM. AFTER POSITIONING A MICROCATHETER INTO THE ANEURYSM SACK, THE PHYSICIAN STARTED DEPLOYING COILS. A FRAMING COIL WAS FIRST PLACED FOLLOWED BY THE HYDROFILL COIL THAT ENCOUNTERED RESISTANCE INSIDE THE MICROCATHETER. DURING ATTEMPT TO PULL BACK, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. CONSEQUENTLY, THE RUPTURED ANEURYSM WAS TREATED. REPORTEDLY, THE PATIENT WAS LEFT WITH SOME NON-SPECIFIED DEFICITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853380 ↗
• MalfunctionSep 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN IMPLANT COIL DETACHED INSIDE OF THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090297 ↗
• MalfunctionFeb 14, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED THAT A STENT AND TWO (2) COILS WERE IMPLANTED DURING AN ELECTIVE TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. AFTER APPROXIMATELY 3-4 MINUTES OF PLACING THE THIRD COIL, RESISTANCE WAS ENCOUNTERED. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED IN THEIR ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE DOING OKAY AND HAD NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339925 ↗