V-Trak 7310-0515-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
- 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 00816777023391), received between May 6, 2023 and Sep 2, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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.
Reports received per month
Most reported problems
Device problems
- Premature Separation2
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.
MalfunctionSep 2, 2025Premature Separation; Premature Separation
AS REPORTED: DURING MCA ANEURYSM COILING, THE PHYSICIAN WAS USING THIS HYDROFILL COIL WHEN IT BECAME LOOSE FROM THE PUSHER WIRE IN THE DISTAL PORTION OF THE HEADWAY DUO BEFORE REACHING THE TARGETED ANEURYSM. THE DUO WAS PULLED OUT WITH THE COIL INSIDE AND THEY WERE ABLE TO PUSH THE COIL OUT OF THE DUO. ANOTHER COIL WAS USED AND THE CASE CONTINUED AS PLANNED WITH NO INJURY TO THE PATIENT. NO OTHER INCIDENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22929690 ↗InjuryMay 6, 2023Premature Separation; Premature Separation
IT WAS REPORTED THROUGH A VOLUNTARY MEDWATCH REPORT # MW5116633 THAT DURING A COIL EMBOLIZATION PROCEDURE, THE COIL PREMATURELY DETACHED PRIOR TO BEING FULLY DEPLOYED IN THE ANEURYSM AND IT EXTENDED INTO THE DISTAL V3 SEGMENT OF THE LEFT VERTEBRAL ARTERY. THIS FOREIGN BODY PLACEMENT REQUIRED THE USE OF A SNARE TO REMOVE THE COIL. CONTROL ANGIOGRAPHY DEMONSTRATED PROGRESSIVE OCCLUSION OF THE ANEURYSM. ANGIOGRAPHY WAS PERFORMED AND SHOWED NO EVIDENCE OF THROMBUS AT THE COIL-PARENT ARTERY INTERFACE OR DISTAL EMBOLI. INFORMATION WAS REQUESTED REGARDING THE PATIENT¿S CURRENT CONDITION; HOWEVER, A RESPONSE WAS NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16883081 ↗
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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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