HydroFill Helical 100930HFIL-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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023315), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A RUPTURED GIANT ACOM ANEURYSM (12MM), THE SECOND COIL WAS A HYDROFILL 9X30. THE COIL WAS PUSHED THROUGH A PROWLER 14 MICROCATHETER. APPROXIMATELY 50% OF THE COIL WAS INSIDE THE ANEURYSM AND RESISTANCE WAS ENCOUNTERED. IT WAS DECIDED TO WITHDRAW THE COIL. DURING THE WITHDRAW MANEUVER, THE COIL DETACHED FROM THE DELIVERY PUSHER PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED USING A SNARE OVER THE TRANSFEMORAL SHEATH. ADDITIONAL COILS WERE PLACE WITH GOOD RESULT. THE PATIENT WAS REPORTED TO BE INTUBATED ON ICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14094804 ↗
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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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