HydroSoft Helical 100308H2HS-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 00816777022936), received between Sep 4, 2020 and Sep 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Stretched1
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.
MalfunctionSep 4, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT STENT-ASSISTED COILING WAS PERFORMED FOR AN ACOM ANEURYSM. DURING RETRACTION OF THE COIL INTO THE MICROCATHETER FOR REPOSITIONING, THE COIL STRETCHED AND THEN DETACHED. MOST OF THE COIL WAS CONTAINED WITHIN THE ANEURYSM SAC AND A SMALL SEGMENT OF STRETCHED COIL EXTENDED INTO THE INTERNAL CAROTID ARTERY. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE ANEURYSM WAS SUCCESSFULLY EMBOLIZED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS REPORTED TO BE "FINE" AND WITHOUT ANY NEUROLOGICAL ABNORMALITIES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10497820 ↗
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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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