HydroSoft 3D 7110-0153-3D-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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777025340), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
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.
MalfunctionSep 25, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT A STENT-ASSISTED COILING OF AN ANEURYSM OF THE LEFT ANTERIOR CHOROIDAL ARTERY WAS BEING PERFORMED WHEN THE MICROCATHETER BEGAN TO LOSE POSITION. AN EMBOLIZATION COIL IMPLANT WAS BEING DEPLOYED AT THE TIME. IT WAS ATTEMPTED TO PUSH THE IMPLANT BACK INTO THE ANEURYSM BUT THE IMPLANT DETACHED UNEXPECTEDLY. THE IMPLANT WAS STUCK BETWEEN THE STENT AND THE VESSEL WALL. THE PATIENT WAS REPORTED TO BE "FINE OTHERWISE" AND THAT THE PHYSICIAN WAS ABLE TO FINISH THE CASE. THERE WAS NO INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20298177 ↗
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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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