V-Trak 7310-0820-A2Recalls & reported problems
Microvention, Inc. · HydroFill 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023438), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- 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.
MalfunctionNov 21, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PHYSCIAN WAS TREATING AN ANEURYSM AND AS THEY WERE PASSING THE COIL THROUGH THE MICROCATHETER RESISTANCE WAS FELT NEAR THE DISTAL END OF THE CATHETER, BUT STILL WITHIN THE MICROCATHETER. AFTER TRYING TO RETREAT THE COIL A LITTLE DUE TO THE RESISTANCE, THEY REALIZED THE COIL HAD BEEN DETACHED FROM THE PUSHER WIRE. THEY PULLED THE MICROCATHETER OUT WITH THE COIL INSIDE AND CONTINUED THE CASE WITH A NEW MICROCATHETER/COIL(S) AND COMPLETED THE CASE. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187545 ↗
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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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