HydroCoil Helical 140203HES-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroCoil Helical (2)
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 00811425021040), received between Jun 15, 2021 and Jun 15, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH A FRED EPI STUDY, ON (B)(6) 2021, A (B)(6) YEAR OLD FEMALE PATIENT RECEIVED EMBOLIZATION TREATMENT FOR A GIANT LEFT CAVERNOUS CAROTID ANEURYSM, PARTLY THROMBOSED, RESPONSIBLE FOR AN ORBITAL APEX SYNDROME WITH OCULOMOTOR DISORDERS AND DECREASED VISUAL ACUITY, IN ASSOCIATION WITH A COMPRESSIVE OPTIC NEUROPATHY. THE PATIENTS SYMPTOMS BEGUN APPROXIMATELY 18 MONTHS PRIOR TO THE INITIAL MANAGEMENT, WHICH WAS PERFORMED IN (B)(6) 2020 BY PARTIAL SEALING OF THE ANEURYSM SAC WITH MULTIPLE COILS FOLLOWED BY ADDITIONAL EMBOLIZATION ON (B)(6) 2021 BY DEPLOYMENT OF AN FDV FRED. PRE PROCEDURE NEUROLOGICAL EVALUATION WAS MRS SCORE 1. AT THE END OF THE TREATMENT, THE FDV FRED FULLY COVERS THE ANEURYSM NECK. THE POST PROCEDURAL ANGIOGRAPHIC RESULT IS A RESIDUAL SAC (RIII) AND THE PARENT ARTERY REMAINS WITHOUT STENOSIS. AFTER TREATMENT, THE PATIENT SHOWED IMPROVEMENT IN VISUAL ACUITY AND OCULOMOTOR DISTURBANCE. PATIENT DISCHARGED (B)(6) 2021. ON (B)(6) 2021 (38DAYS POST PROCEDURE COMPLICATION), THE PATIENT VISUAL ACUITY AND OCULOMOTOR DISTURBANCE WORSENED. ON (B)(6) 2021, PATIENT HAD A NEURO OPHTHALMOLOGY CONSULTATION WHICH REVEALED A WORSENING OF THE STRABISMUS FOR WHICH IT WAS A
Patient problems: Aneurysm; Visual Impairment
MAUDE report 12005447 ↗
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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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