HydroSoft Helical 100308H2HS-V-NRecalls & 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 00810170019579), received between Jan 16, 2020 and Jan 16, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT UPON REMOVAL FROM THE OUTER BOX, THE POUCH CONTAINING THE STERILE EMBOLIZATION COIL WAS FOUND TO BE UNSEALED. THE DEVICE WAS NOT USED IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9599336 ↗
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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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