HydroSoft Helical 100152H2HS-V-ARecalls & 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 00811425026410), received between Nov 23, 2016 and Nov 23, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Issue” (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
- Device Issue1
- Difficult to Advance1
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.
MalfunctionNov 23, 2016Device Issue; Difficult to Advance; Device Issue; Difficult to Advance
IT WAS REPORTED FROM (B)(6) THAT DURING TREATMENT OF ANEURYSM, FRICTION WAS ENCOUNTERED WHEN COIL WAS REMOVED FROM THE HOOP. THE PUSHER WIRE AND THE COIL WERE PULLED FROM THE PROXIMAL END OF THE INTRODUCER SHEATH. THE COIL WAS REINTRODUCED INTO THE SHEATH. UPON PUSHING THE COIL INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED NOT ALLOWING THE COIL TO ADVANCE. UPON REMOVAL OF THE PUSHER WIRE, THE IMPLANT PORTION OF THE COIL WAS IN THE MICROCATHETER AND PUSHER PORTION OUTSIDE OF THE MICROCATHETER. THE PATIENT WAS REPORTED TO HAVE WOKEN UP FROM TREATMENT WITH NO DEFICIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124763 ↗
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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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