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HydroFrame 10 Advanced 100619HFRM-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
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816777023551), received between Apr 9, 2020 and Aug 10, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 Component3
  • Device-Device Incompatibility2
  • Difficult to Remove1
  • Unraveled Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

    IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ADVANCING AN EMBOLIZATION COIL IMPLANT IN THE CATHETER, FRICTION WAS ENCOUNTERED. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE IMPLANT COIL HAD DETACHED FROM THE DELIVERY PUSHER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12305351 ↗
  • InjuryFeb 10, 2021Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device-Device Incompatibility

    DURING TREATMENT OF A CAVERNOUS FISTULA COILING PROCEDURE, MULTIPLE COILS WERE DELIVERED SUCCESSFULLY IN THE FACIAL VEIN-OPHTHALMIC VEIN INTO THE CAVERNOUS SEGMENT. THE 6X19 COIL WAS ADVANCED THROUGH THE MICROCATHETER INTO THE ARTERIAL SEGMENT. RESISTANCE WAS REPORTED DURING ADVANCEMENT OF THE COIL UNTIL THE COIL STOPPED ADVANCING IN THE MICROCATHETER. UPON REMOVAL FROM THE MICROCATHETER HUB, THE COIL UNRAVELED. THE COIL WAS REMOVED BY CUTTING THE HUB FROM THE MICROCATHETER AND TRACKING A SNARE PARALLEL TO THE CATHETER TO REMOVE THE SYSTEM WITHIN THE GUIDE CATHETER FROM THE PATIENT SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11311002 ↗
  • MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING REPOSITIONING OF AN EMBOLIZATION COIL IN AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE COIL DETACHED IN THE ANEURYSM. THE ENTIRETY OF THE DETACHED PORTION OF THE IMPLANT WAS INSIDE OF THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9946915 ↗

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Sources and updates

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