HydroSoft 3D 100306HFRM-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 00816777026576), received between Nov 26, 2020 and Jun 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 Component2
- Separation Failure1
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 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY DURING TREATMENT OF A GIANT ANEURYSM. THE DISTAL PORTION OF THE COIL WAS LEFT IN THE ANEURYSM AND THE PROXIMAL PORTION WAS REMOVED WITH THE DELIVERY PUSHER, AS IT WAS STILL ATTACHED TO THE PUSHER. THERE WAS NO INTERVENTION OR PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119212 ↗MalfunctionNov 26, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING DEPLOYMENT OF AN EMBOLIZATION COIL, THE COIL WOULD NOT DETACH. DURING WITHDRAWAL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE ANEURYSM WITH THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT INJURY, OR ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10909757 ↗
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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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