V-Trak 7110-0202-3D-A2Recalls & reported problems
Microvention, Inc. · HydroSoft 3D · Class 2 · Implant
All models of V-Trak (75)
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 00816777025364), received between May 18, 2017 and May 23, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- 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.
MalfunctionMay 23, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT THE COIL DEPLOYED HALF IN THE BRAIN, HALF IN THE CATHETER. NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081774 ↗MalfunctionMay 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A 3MM ANTERIOR COMMUNICATING ARTERY ANEURYSM VIA THE RIGHT INTERNAL CAROTID ARTERY. AN EMBOLIZATION COIL WAS ADVANCED QUICKLY THROUGH THE MICROCATHETER WITHOUT USE OF FLUOROSCOPY AND A SLIGHT "POP" WAS NOTED. UNDER FLUOROSCOPY, THE COIL WAS FOUND TO HAVE DEPLOYED IN THE ANEURYSM WITHOUT USE OF THE CONTROLLER. AS THE PUSHER WAS RETRACTED, THE COIL IMPLANT AND DISTAL PUSHER DID NOT MOVE. THE PROXIMAL HALF OF THE PUSHER WAS REMOVED FROM THE MICROCATHETER AND IT WAS NOTED TO BE FRACTURED. THE NON-DETACHED COIL IMPLANT AND FRACTURED DISTAL END OF THE PUSHER WAS CAREFULLY REMOVED ALONG WITH THE MICROCATHETER. ALL COMPONENTS OF THE COIL WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6577541 ↗
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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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