HydroFrame Framing Coil 100931HFRM-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170015069), received between Dec 10, 2021 and Dec 10, 2021 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionDec 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE FIRST COIL OF THE CASE EXPERIENCED RESISTANCE WHEN GOING FROM THE SHEATH TO THE MICROCATHETER AND THE SAFETY MARKERS MOVED. IT WAS DECIDED TO REMOVE THE COIL AND LOOK AT ITS INTEGRITY WITHOUT OBSERVING ANY DAMAGE. THE COIL WAS REINTRODUCED WITH IMPROVED PASSAGE AND THE PHYSICIAN CONTINUED RELEASING THE COIL WITH FLUOROSCOPY CONTROL. ADDITIONAL COILS WERE RELEASED WITHOUT ANY PROBLEM USING THE SAME MICROCATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12977145 ↗
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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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