HydroFrame 10 Advanced 7110-0931Recalls & 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 00811425029701), received between Sep 9, 2024 and Sep 9, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE CLINICAL STUDY, RAGE: SUBJECT PRESENTED FOR ROUTINE FOLLOW UP ANGIOGRAM ON (B)(6) 2019. ANEURYSM RECURRENCE WAS DISCOVERED. ON (B)(6) 2019 COIL EMBOLIZATION WAS PERFORMED TO TREAT RECURRENCE. FOLLOW UP ANGIOGRAM ON (B)(6) 2019 WAS PERFORMED AND CONFIRMED ANEURYSM OCCLUSION WITH NO COMPLICATIONS. RESOLVED WITHOUT SEQUELAE.
Patient problems: Aneurysm; Obstruction/Occlusion
MAUDE report 20171449 ↗
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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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