HydroSoft 3D 100102HFRM-V-3D-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft 3D (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777026439), received between May 1, 2020 and Apr 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Premature Separation
AS REPORTED: ON APRIL 1, 2026, IN INTERVENTIONAL NEURORADIOLOGY, THE COIL DEPLOYED WITHIN THE MICROCATHETER. THE COIL DETACHED INTO THE LUMEN OF THE MICROCATHETER. CASE WAS COMPLETED BY USING ANOTHER COIL. THE ENTIRE SYSTEM WAS WITHDRAWN, AND THE SECOND COIL WAS SUCCESSFULLY USED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE INCIDENT WAS ISOLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25037696 ↗MalfunctionMay 1, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING INSERTION OF THE COIL INTO THE MICROCATHETER, THE ZEBRA MARKERS WERE NOTED TO BE MISSING. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "NORMAL."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10018277 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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