HydroFrame 10 Advanced 100612HFRM-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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023544), received between Mar 11, 2022 and Jul 22, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material 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
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
- Migration1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Stroke/CVA1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE COIL BROKE DURING INSERTION AND HAD TO BE RECOVERED FROM THE PATIENT. THEY HAD ALREADY PLACED SOME COILS INTO THE ANEURYSM. THE AFFECTED COIL COULD BE ADVANCED THROUGH THE MICROCATHETER WITHOUT ANY ISSUES AND WAS DEPLOYED INTO THE ANEURYSM FOR APPROXIMATELY THE FIRST 2 MILLIMETERS. AFTER THAT, THE MICROCATHETER WAS PUSHED OUT OF THE ANEURYSM, AND THE COIL COULD NO LONGER BE MANIPULATED VIA THE PUSHER WIRE. THE COIL APPEARS TO HAVE BROKEN INSIDE THE MICROCATHETER ¿ BY ADVANCING A GUIDEWIRE THROUGH THE MICROCATHETER, THE DISTAL PART BEYOND THE FRACTURE SITE WAS CLAMPED. THIS ALLOWED THE DETACHED COIL TO BE RETRIEVED FROM THE PATIENT. THE PATIENT IS DOING WELL ¿ THE RECOVERY CAUSED NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22568831 ↗MalfunctionMay 17, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED PREMATURELY INSIDE THE MICROCATHETER. THE IMPLANT WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. THERE WAS NO INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19346905 ↗MalfunctionMar 11, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT OF A RIGHT MEDIA ANEURYSM ON (B)(6) 2021 FOUR HYDROFRAME-10 AV COILS WERE DEPLOYED WITHOUT INCIDENT. ON (B)(6) 2021 IMAGING REVEALED SOME SMALL MICRO-INFARCTS. THE PATIENT WAS REPORTED IN GOOD CONDITION WITHOUT PERMANENT NEUROLOGICAL DAMAGE. NO SECONDARY INTERVENTION WAS TAKEN AND NO SEQUELAE WAS REPORTED.
Patient problems: Stroke/CVA
MAUDE report 13741184 ↗
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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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