HydroFrame Framing Coil 181445HFRM-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 00810170015182), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
- Unraveled Material1
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.
InjuryDec 16, 2021Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A GIANT ANEURYSM ON THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), DIFFICULT PLACEMENT WAS ENCOUNTERED WITH THE FIRST COIL. A SECOND COIL WAS USED WITH THE SAME MICROCATHETER FROM A DIFFERENT MANUFACTURER. THE COIL WAS ADVANCED WITH 50% OF THE COIL WITHIN THE ANEURYSM WHEN THE COIL BECAME STUCK WITHIN THE MICROCATHETER AND COULD NOT BE ADVANCED AND STRETCHED UPON WITHDRAWAL. THE MICROCATHETER AND COIL SYSTEM WERE CUT OFF AT THE PROXIMAL END. A SNARE WAS ADVANCED OVER THE MICROCATHETER AND ALL PRODUCTS WERE COMPLETELY REMOVED FROM THE PATIENT. BECAUSE OF THE SIZE OF THE ANEURYSM, THE DECISION WAS MADE TO OCCLUDE THE RIGHT COMMON ANTERIOR ARTERY. THE OCCLUSION WAS PERFORMED WITH GOOD RESULT AND THE PATIENT HAD CROSS FLOW FROM THE LEFT. THERE WAS NO REPORT OF INJURY TO THE PATIENT, WHO WAS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13021855 ↗
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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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