HydroSoft 3D 100256HFRM-V-3D-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft 3D (26)
Data updated Oct 18, 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 00816777026545), received between Mar 4, 2021 and Jun 9, 2021 — classified as 2 malfunctions.
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
- Physical Resistance/Sticking1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
IT WAS REPORTED THAT DURING EMBOLIZATION OF AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, AN EMBOLIZATION COIL IMPLANT ENCOUNTERED FRICTION IN THE MICROCATHETER. THE COIL DETACHED WITHIN THE CATHETER UPON ATTEMPTED REMOVAL AND THE PHYSICIAN REMOVED THE DETACHED PORTION THROUGH THE HUB. THERE WAS NO REPORTED INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971213 ↗MalfunctionMar 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE COIL DETACHED WITHOUT THE USE OF THE DETACHMENT CONTROLLER. THE LAST SEGMENT OF COIL WAS PUSHED IN THE ANEURYSM USING THE DELIVERY PUSHER. THERE WAS NO REPORTED PATIENT INJURY, SEQUELA, OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11418355 ↗
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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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