HydroFrame 10 Advanced 7110-0728Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812636020341), received between Apr 13, 2017 and Apr 13, 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 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Separation Failure1
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.
MalfunctionApr 13, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure
IT WAS REPORTED THAT AFTER POSITIONING AN EMBOLIZATION COIL IN AN ANEURYSM, THE COIL WOULD NOT DETACH. MULTIPLE ATTEMPTS WERE MADE TO DETACH THE COIL, WITHOUT SUCCESS. DURING REMOVAL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED BACK INTO THE ANEURYSM WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6492474 ↗
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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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