HydroFill Helical 100204HFIL-V-ARecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroFill Helical (11)
Data updated Oct 18, 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 00811425026748), received between Jun 3, 2016 and Jun 3, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED FROM (B)(6) THAT DURING THE TREATMENT OF A MIDDLE CEREBRAL ANEURYSM (LEFT M1), A STENT ASSISTED COILING OF THE MCA WITH BALLOON REMODELING. A COIL WAS POSITIONED AT THE VESSEL FROM THE ANEURYSM TO PROTECT THE NECK. UPON, POSITIONING, THE COIL WOULD NOT ADVANCE OR RETRACT. IT WAS DECIDED TO DETACH THE COIL AT THIS LOCATION, HOWEVER THE COIL WOULD NOT DETACH. UPON WITHDRAWAL, THE PUSHER BROKE. THE EMBOLIZATION COIL WAS PUSHED INSIDE THE ANEURYSM USING THE PUSHER AND THE PROCEDURE WAS CONTINUED. THE COIL WAS PUSHED TO THE LOCATION OF THE VESSEL, HOWEVER THIS WAS NOT THE DESIRED SITE (REF. 2032493-2016-00117). NO ADDITIONAL INTERVENTION WAS TAKEN TO REMOVE THE COIL. AN ADDITIONAL COIL WAS DEPLOYED (REFERENCED IN THIS REPORT, (2032493-2016-00118) TO THE ANEURYSM WITH SIMILAR ADVANCEMENT/NAVIGATION DIFFICULTY AS THE FIRST. IT WAS DECIDED TO DETACH THE COIL. DETACHMENT WAS SUCCESSFUL, HOWEVER THE VESSEL WAS NOW WITHOUT CIRCULATION. THE PATIENT WAS REPORTED TO WAKE UP WITHOUT PROBLEM, HOWEVER A LITTLE APHASIA WAS REPORTED. ON (B)(6) 2016 IT WAS REPORTED THAT THE PATIENT WAS REPORTED TO BE VERY WELL TWO DAYS FOLLOWING THE PROCEDURE. NO CLINICAL DEFICITS WERE REPORTED.
Patient problems: Aneurysm
MAUDE report 5697797 ↗
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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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