HydroFrame 10 Advanced 7110-0515Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroFrame 10 Advanced (22)
Data updated Oct 16, 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 00811425029596), received between Nov 4, 2024 and Nov 4, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE RAGE CLINICAL STUDY: MRA (APPROXIMATELY TWO WEEKS PRIOR TO THE EVENT DATE) SHOWED A RECURRENT ACOM ANEURYSM NECK FILLING MEASURING BETWEEN 3 AND 5 MM WITH COIL COMPACTION SUGGESTED. THE SUBJECT UNDERWENT RETREATMENT ON WITH THE PLACEMENT OF A STENT. THE INDEX PROCEDURE WAS PERFORMED FOUR MONTHS PRIOR TO THE EVENT DATE.
Patient problems: Aneurysm
MAUDE report 20605095 ↗
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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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