HydroFrame 10 Advanced 100510HFRM-V-ARecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811425027080), received between Mar 10, 2017 and Mar 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Difficult To Position1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2017Detachment Of Device Component; Difficult To Position; Detachment Of Device Component; Difficult To Position
IT WAS REPORTED THAT DURING REPOSITIONING OF A HYDROFRAME COIL IN AN ANEURYSM, THE COIL UNEXPECTEDLY DETACHED INSIDE THE MICROCATHETER WITHOUT USE OF THE V-GRIP DETACHMENT CONTROLLER. THE COIL WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY, AND THE PATIENT WAS REPORTED TO BE OKAY AT HOSPITAL DISCHARGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6397341 ↗
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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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