HydroFill Helical 100720HFIL-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 00816777024428), received between Sep 9, 2021 and Sep 9, 2021 — 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
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.
InjurySep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM THE COIL WAS REPORTED TO HAVE DETACHED INSIDE THE MICROCATHETER. THE COIL WAS PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. THE CATHETER WAS WITHDRAWN AND THE COIL WAS REMOVED USING A TIGER RETRIEVER. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS. THE PATIENT WAS REPORTED TO BE DOING WELL. NO PATIENT INJURY WAS INCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450833 ↗
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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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