V-Trak 7210-0515-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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023230), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2025Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WAS DEPLOYED AND DETACHED IN A COIL MASS OF MULTIPLE COILS. WHILE THEY WERE PLACING THE LAST COIL, IT DETACHED UNEXPECTEDLY WITH HALF OF THE COIL LENGTH IN THE ANEURYSM AND THE OTHER HALF LEFT IN THE PARENT VESSEL. IT WAS REPORTED THAT THE PATIENT IS FINE AND THE SURGEON IS NOT CONCERNED. THE SURGEON PLACED STENTS ALONG SIDE THE PORTION OF THE COIL THAT WAS STILL IN THE VESSEL TO "PIN IT" SO IT WOULD NOT MIGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23847124 ↗
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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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