HydroFrame 10 Advanced 100515HFRM-V-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroFrame 10 Advanced (22)
Data updated Oct 18, 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 00812636023533), received between Aug 22, 2024 and Aug 22, 2024 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation1
- Stretched1
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.
InjuryAug 22, 2024Stretched; Premature Separation; Stretched; Premature Separation
AS REPORTED: IT WAS IDENTIFIED THAT WHEN A 5X15 HYDROFRAME COIL WAS PLACED, IT HAD APPARENTLY RELEASED WITHOUT HAVING BEEN COMPLETELY IMPLANTED, SINCE A LARGE PART OF THE DEVICE WAS STILL IN THE MICROCATHETER DURING A CEREBRAL ANEURYSM OCCLUSION PROCEDURE IN THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY. THE DOCTOR MANAGED TO EXTRACT IT USING HIS OWN TECHNIQUE AND UPON REMOVING IT, IT WAS EVIDENT THAT IT HAD LENGTHENED AND THIS PREVENTED ITS PROPER PLACEMENT. THE PROCEDURE ENDS WITHOUT AFFECTING THE PATIENT. PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20043218 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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