HydroSoft 3D 7110-0152-3D-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft 3D (26)
Data updated Oct 16, 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 00816777025333), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
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.
InjuryMar 31, 2026Malposition of Device
IT WAS REPORTED THAT THE PHYSICIAN SELECTED THE ANEURYSM WITH A HEADWAY 17 AND .014 GUIDEWIRE. AFTER HE ADVANCED THE COIL IN THE ANEURYSM HE DETACHED, AND THE COIL GOT STUCK IN THE CATHETER AS HE WAS PULLING BACK THE HEADWAY 17. PART OF THE COIL STAYED IN THE ANEURYSM AND PART OF THE COIL REMAINED IN THE PARENT VESSEL. THE COIL DID NOT EXTEND VERY FAR INTO THE VESSEL, SO THE PHYSICIAN DECIDED TO LEAVE THE COIL ALONE AND PUT THE PATIENT ON DAP THERAPY. THE OUTCOME WAS THAT THE PATIENT DID WELL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749098 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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