V-Trak 7210-0154-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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023032), received between Feb 5, 2020 and Feb 15, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
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.
InjuryFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE, THE TWO COILS UNINTENTIONALLY DETACHED FROM THE PUSHER IN THE MICROCATHETER DURING MANIPULATION INTO A LARGE ANEURYSM. THE PHYSICIAN USED A SNARE DEVICE TO REMOVED THE ENTIRE COILS FROM THE PATIENT. THE PATIENT HAD SEVERAL COMPLICATIONS UNRELATED TO THE COILS. THE PATIENT CURRENT STATUS IS STABLE. THIS REPORT 1 OF 2. REFERENCE MFR. REPORT# 2032493-2022-00055.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13536833 ↗InjuryFeb 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING TREATMENT OF A RUPTURED ANEURYSM, AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY IN THE PARENT VESSEL. A STENT WAS USED TO AFFIX THE IMPLANT COIL TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9674233 ↗
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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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