V-Trak 7210-0254-A2Recalls & reported problems
Microvention, Inc. · HydroSoft Advanced · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023100), received between Nov 22, 2021 and May 20, 2025 — classified as 1 injury, 1 malfunction.
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
- 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.
InjuryMay 20, 2025Separation Problem; Separation Problem
AS REPORTED: DR. WAS PERFORMING A COILING OF AN MCA BIFURCATION ANEURYSM. THE 2.5/4CM HYDROSOFT WAS INSERTED BUT WOULD NOT DETACH AFTER PLACEMENT. DR. TRIED TO RECAPTURE THE HYDROSOFT COIL BACK INTO THE MICROCATHETER. DURING THE ATTEMPTED RECAPTURING OF THE COIL, IT DETACHED BUT LEFT A PORTION OF THE PROXIMAL END OF THE COIL IN THE PARENT VESSEL. DR. HAD TO PLACE A STENT TO SECURE THE PROXIMAL END OF THE COIL AGAINST THE VESSEL WALL. CASE WAS COMPLETED WITH THE ANEURYSM BEING COILED AND A STENT WAS PLACED TO SECURE COIL AGAINST VESSEL WALL. PATIENT WOKE UP NEUROLOGICALLY INTACT AND WAS FINE POST OP 24 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22057476 ↗MalfunctionNov 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE PUSHER UNINTENTIONALLY DETACHED IN THE MICROCATHETER AFT DEPLOYMENT. THE "ENITIRE" COIL WAS REMOVED COIL FROM THE PATIENT. ANOTHER COIL WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858515 ↗
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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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