HydroSoft 3D 100254HFRM-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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777026538), received between Nov 20, 2023 and Sep 26, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Premature Separation1
- Separation Problem1
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.
InjurySep 26, 2024Device Dislodged or Dislocated; Separation Problem; Device Dislodged or Dislocated; Separation Problem
AS REPORTED: FOURTH COIL WAS DEPLOYED INTO RUPTURED ANEURYSM, COULD NOT GET ENTIRE LENGTH OF THE COIL INTO THE ANEURYSM, APPROXIMATELY 1CM OF COIL REMAINED PROTRUDING ON EACH OF 3 ATTEMPTS. INCREASED FRICTION FELT MANIPULATING COIL IN ADVANCED STRAIGHT MICROCATHETER, SO ATTEMPTED TO REMOVE COIL. HOWEVER, THE PUSHER WIRE OF THE COIL SNAPPED PROXIMALLY. DISTAL FRAGMENT OF COIL AND PUSHER WIRE WERE REMOVED WITH A SNARE AND THE REMAINING TAIL OF COIL WAS STENTED IN PLACE TO SUCCESSFULLY COMPLETE THE PROCEDURE. SURGICAL INTERVENTION IN FORM OF STENT BEING DEPLOYED, HOWEVER NO ADVERSE EFFECTS TO PATIENT NOTED AS A RESULT OF THIS PROCEDURE. NO CHANGE TO MRS PRE / POST PROCEDURE. PROCEDURE PERFORMED: ACOM ANEURYSM EMBOLISATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20313861 ↗MalfunctionNov 20, 2023Premature Separation; Premature Separation
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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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