HydroFrame Framing Coil 180931HFRM-V-A2Recalls & 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 00816777023803), received between Oct 24, 2022 and Oct 24, 2022 — 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.
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.
InjuryOct 24, 2022Premature Separation; Premature Separation
IT WAS REPORTED THE COIL HAD DETACHED ON ITS OWN. PHYSICIAN WAS PERFORMING A STENT COIL REPAIR OF BASILAR TIP ANEURYSM. LVIS JR DEPLOYED IN RIGHT P1 AND HW DUO JAILED. HW DUO SLIPPED BACK INTO BASILAR. WAS UNABLE TO RESHEATH COIL OR ADVANCE HW DUO OVER THE COIL. PHYSICIAN USED MICROSNARE TO RETRIEVE COIL. FINISHED COILING BY CROSSING LVIS JR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657884 ↗
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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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