HydroFill Helical 100620HFIL-V-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroFill Helical (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777024411), received between Apr 5, 2018 and Aug 21, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (3 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.
Reports received per month
Most reported problems
Device problems
- Premature Separation3
- Detachment Of Device Component1
- Difficult to Remove1
- Migration1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2026Unraveled Material; Migration; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381055 ↗MalfunctionJun 30, 2025Premature Separation; Premature Separation
AS REPORTED: THE HYDROFILL 6/20 COIL BROKE IN THE MICROCATHETER DURING THE COIL'S ASCENT TO THE ANEURYSM, IN A PATIENT ADMITTED FOR SAH AFTER ANEURYSM RUPTURE. THE DOCTOR REMOVED BOTH THE COIL AND MICROCATHETER. COIL WAS STUCK IN THE MICROCATHETER. NO SNARE WAS USED. NO CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22355900 ↗MalfunctionSep 12, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND THEN DETACHED UNEXPECTEDLY. THERE WAS NO INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO BE "FINE AND WELL." ANOTHER EMBOLIZATION COIL IMPLANT ENCOUNTERED THE SAME ISSUE DURING THE CASE AND WAS REPORTED UNDER A SEPARATE MEDICAL DEVICE REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207961 ↗InjuryApr 5, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove
IT WAS REPORTED THAT DURING POSITIONING OF AN EMBOLIZATION COIL IN AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE COIL DETACHED IN THE INTENDED AREA. THE DETACHED COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7399806 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page