HydroFrame 10 Advanced 100510HFRM-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 00812636023526), received between Jul 17, 2024 and Jul 17, 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
- Intracranial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE RAGE CLINICAL STUDY THAT THE FOLLOWING EVENT WAS REVIEWED BY INDEPENDENT REVIEWER AND WAS DETERMINED TO BE POSSIBLY RELATED TO STUDY DEVICE AND PROBABLY RELATED TO STUDY PROCEDURE: INTRA-VENTRICULAR HEMORRHAGE. FOUR DAYS POST-PROCEDURE, A REPEAT NON-CONTRAST HEAD CT DEMONSTRATED MORE HEMORRHAGE IN THE POSTERIOR FOSSA AND INTRAVENTRICULAR HEMORRHAGE. AFTER REVERSAL OF ANTICOAGULATION, THE PATIENT UNDERWENT PLACEMENT OF A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN. CEREBRAL ANGIOGRAPHY RESULTED IN COMPLETE OCCLUSION OF VERTEBROBASILAR JUNCTION ANEURYSM. THE OUTCOME WAS REPORTED TO BE "RESOLVED WITHOUT SEQUELAE."
Patient problems: Intracranial Hemorrhage
MAUDE report 19767761 ↗
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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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