HydroFrame 10 Advanced 100931HFRM-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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777023605), received between Nov 20, 2020 and Dec 12, 2024 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2024Premature Separation; Premature Separation
IT WAS ORIGINALLY REPORTED THAT: " WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE COIL IN THE ANEURYSM, HE NOTICED IT WAS ALREADY DETACHED. AS PER THE PHYSICIAN, THE COIL IS DEFECTIVE." ADDITIONAL INCIDENT INFORMATION WAS RECEIVED. AS PER THE PHYSICIAN, THE COIL WAS INSERTED INTO THE CATHETER AND ADVANCED INTO THE ANEURYSM. UPON PLACEMENT, THE PHYSICIAN IDENTIFIED AN ISSUE WITH THE COIL AND THEREFORE ATTEMPTED TO RETRIEVE IT. HOWEVER, THE RETRIEVAL WAS UNSUCCESSFUL, INDICATING THAT THE COIL WAS DETACHED FROM THE BEGINNING. CONSEQUENTLY, THE CATHETER AND COIL HAD TO BE REMOVED AND THE PLANNED PROCEDURE COULD NOT BE COMPLETED. THE PHYSICIAN ONLY DEPLOYED 10% OF THE COIL AND THEREFORE THE COIL WAS NOT COMPLETELY DETACHED WITHIN THE ANEURYSM. PATIENT WAS LATER ON ADMITTED FOR A FLOW DIVERTER PROCEDURE WITH A DIFFERENT PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918581 ↗MalfunctionNov 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING COIL EMBOLIZATION TO TREAT AN INTRACRANIAL ANEURYSM, THE EMBOLIZATION COIL DETACHED DURING ADVANCEMENT. THE COIL WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY, OR ADDITIONAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10878336 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page