HydroFrame Framing Coil 181347HFRM-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170015175), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Premature Separation; Premature Separation
AS REPORTED, A 13MM X 47 CM HYDROFRAME 18 WAS THEN INSERTED INTO THE MICROCATHETER. EXCESSIVE RESISTANCE WAS FELT WHEN INSERTING THIS COIL AND WHEN ATTEMPTS WERE MADE TO REMOVE THE COIL IT DETACHED IN THE MICROCATHETER. THE JAILED HEADWAY DUO WAS THEN UNABLE TO BE USED TO DELIVER FURTHER COILS TO THE ANEURYSM RESULTING IN SUB OPTIMAL TREATMENT OF THE TARGET. IT IS NOT POSSIBLE TO RETREAT WITH FURTHER COILS DUE TO THE FLOW DIVERTING STENT INSITU SO THE PATIENT WILL BE MONITORED AT REGULAR FOLLOW UP INTERVALS AND A DECISION WILL BE MADE AS TO WHETHER THEY REQUIRE ADDITIONAL TREATMENT AND IF SO, THE NATURE OF THAT TREATMENT WILL BE DETERMINED IN THE FUTURE. NO PATIENT INJURY REPORTED, HOWEVER THE INCIDENT HAS RESULTED IN AN INCOMPLETE TREATMENT OF A LARGE ANEURYSM AND LIMITED THE OPTIONS FOR FURTHER TREATMENT OF THE LESION. THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22734334 ↗
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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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