HydroFrame 10 Advanced 100715HFRM-V-ARecalls & 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 00811425027141), received between Feb 26, 2017 and Feb 26, 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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Difficult To Position1
- Stretched1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2017Detachment Of Device Component; Difficult To Position; Stretched; Detachment Of Device Component; Difficult To Position; Stretched
IT WAS REPORTED THAT DURING THE TREATMENT OF A PSEUDOANEURYSM OF THE RIGHT INTERNAL ILIAC ARTERY, THE EMBOLIZATION COIL WAS POSITIONED IN PLACE. UPON DETACHMENT, THE COIL DID NOT DETACH. THE DEVICE WAS PULLED TO WITHDRAWAL, HOWEVER THE DELIVERY PUSHER STRETCHED AND BROKE. A PORTION OF THE STRETCHED DELIVERY PUSHER SEGMENT WAS REMOVED, BUT THE OTHER PORTION REMAINED IN THE VESSEL. THE PATIENT WAS REPORTED TO BE OKAY. ADDITIONAL INFORMATION/CLARIFICATION RECEIVED ON 4 FEB 2017, INDICATED THE FOLLOWING: THE EMBOLIZATION COIL WAS WITHIN THE ANEURYSM. ATTEMPTS WERE MADE TO REMOVE THE DEVICE BY PULLING. IT WAS STATED THAT THE PHYSICIAN PULLED THE DEVICE VERY HARD. THESE ATTEMPTS WERE UNSUCCESSFUL. THE STRETCHED PORTION OF THE DEVICE (DELIVERY PUSHER) WAS LEFT IN PLACE, NO OTHER INTERVENTION WAS TAKEN. IT WAS REPORTED THAT THE PHYSICIAN EMPHASIZED THAT HE TRIED TO REMOVE THE DEVICE WITH TOO MUCH FORCE. IT WAS INDICATED THAT IT WAS NOT THE FAULT OF THE DEVICE. THE PATIENT WAS REPORTED TO BE OKAY WITH NO NEGATIVE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6359610 ↗
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