HydroFrame 10 Advanced 100715HFRM-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777023568), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or 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 or Device Component1
- Separation Failure1
- Stretched1
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.
MalfunctionNov 15, 2019Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT AN EMBOLIZATION COIL HAD DIFFICULTY DETACHING WITHIN THE ANEURYSM. ADDITIONALLY, THE COIL COULD NOT BE ADVANCED OR RETRACTED. THE COIL WAS ULTIMATELY DETACHED WITHIN THE ANEURYSM. THE PUSHER BROKE UPON REMOVAL. NO INTERVENTION OR PATIENT INJURY WAS REPORTED. THE PATIENT WAS REPORTED TO BE DOING "WELL."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9330435 ↗
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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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