HydroFill Helical 100515HFIL-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777023308), received between Apr 29, 2022 and Oct 3, 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Premature Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PHYSICIAN SELECTED A 100515HFIL-V DURING A COILING. UPON ADVANCEMENT OF THE 100515HFIL-V THROUGH AN SL-10, THE COIL DETACHED ITSELF AROUND HALFWAY THOUGH THE MICROCATHETER. THE MICROCATHETER AND COIL WERE REMOVED. THE PATIENT IS REPORTED STABLE. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20364355 ↗MalfunctionSep 13, 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 2032493-2024-00679.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20218178 ↗MalfunctionAug 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL JAILING PROCEDURE TO TREAT A BASILAR ANEURYSM, THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER WHEN IT WAS APPROACHING THE ANEURYSM. THE FLOW DIVERTER WAS RECAPTURED AND THE ENTIRE COIL AND CATHETER WERE REMOVED SUCCESSFULLY FROM THE PATIENT. NO PATIENT INJURY OR INTERVENTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15154363 ↗MalfunctionApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING EMBOLIZATION TREATMENT OF A PCOM ANEURYSM, THE IMPLANT COIL DETACHED UNEXPECTEDLY. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THE CASE WAS SUCCESSFULLY COMPLETED WITH OTHER COILS. THERE WAS NO REPORTED INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14256417 ↗
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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.
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