V-Trak 7210-0208-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 00816777023094), received between May 4, 2023 and May 4, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH A RAGE STUDY, THE PATIENT RECEIVED ENDOVASCULAR TREATMENT AND AFTER INSERTION OF THE FOURTH COIL, IT WAS NOTED THAT THERE WERE COILS PROTRUDING AT NECK WITH A SMALL CLOT FORMATION AT THE NECK OF THE ANEURYSM THAT SHOWED NARROWING IN THE SUPERIOR M2 BRANCH AND DIMINISHED BRANCH FILLING COMPARED TO PREVIOUS. A 14MG OF INTEGRELLIN INTRA-ARTERIAL INFUSION WAS GIVEN. IMAGES SHOWED DESOLATION OF CLOT. THE FOURTH COIL WAS PULLED OUT AND HELPED RESUME FLOW IN BOTH M2 BRANCHES, WITH NO RESTRICTION. THE FOURTH COIL WAS NOT DEPLOYED, AND 1.45MG VERAPAMIL WAS GIVEN TO RELAX BLOOD VESSELS, 160 MH ASA AND 40 PANTOLOC IN ANGIO SUITE. THE EVENT RESOLVED WITHOUT SEQUELAE ON 17APR2022.
Patient problems: Thrombosis/Thrombus
MAUDE report 16873761 ↗
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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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