HydroFrame 10 Advanced 100415HFRM-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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777026217), received between Jun 18, 2021 and May 20, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 Component2
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE EMBOLIZATION TREATMENT, THE IMPLANT COIL UNINTENTIONALLY DETACHED DURING RETRACTION INTO THE DISTAL END OF THE MICROCATHETER. A SNARE DEVICE WAS USED TO REMOVE THE COIL FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14459768 ↗InjuryJun 18, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TREATMENT OF AN MCA ANEURYSM, THE COIL STRETCHED DURING POSITIONING AND DETACHED FROM THE DELIVERY PUSHER. THROMBUS FORMATION WAS REPORTED. TIROFIBAN WAS ADMINISTERED AND THE THROMBUS WAS LYSED. NO PATIENT HARM WAS REPORTED. THE PATIENT IS REPORTED TO BE "WELL OFF."
Patient problems: Thrombosis/Thrombus
MAUDE report 12029071 ↗
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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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