HydroSoft Helical 100304H2HS-V-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft Helical (21)
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 00816777021403), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 malfunction.
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.
MalfunctionFeb 6, 2026Premature Separation
AS REPORTED: DR. WAS TREATING A RUPTURED PICA ANEURYSM ON THE RIGHT. A COIL EMBOLIZATION WAS PLANNED AS THE TREATMENT. AFTER PLACING SEVERAL MV COILS, A HYDROSOFT 3-4 WAS CHOSEN. THE COIL HAD TO BE REPOSITIONED IN THE ANEURYSM. WHEN DR. TRIED TO REMOVE THE COIL FROM THE ANEURYSM, IT PREMATURELY DETACHED. THERE WAS ONLY ONE LOOP REMAINING IN THE ANEURYSM. DR. WAS ABLE TO REMOVE THE COIL FROM THE ANEURYSM AND PATIENT BODY BY PULLING BACK THE MICROCATHETER. COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT BODY COMPLETELY. THE COIL WAS EXCHANGED TO A HYDROSOFT OF SAME SIZE AND THE EXAMINATION COMPLETED. THE PATIENT IS DOING WELL. NO INJURY CAUSED BY THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283737 ↗
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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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