HydroSoft 3D 7110-0203-3D-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft 3D (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816777025371), received between Jan 29, 2021 and Dec 5, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Aneurysm1
- Thrombosis/Thrombus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION WAS RECEIVED, PLEASE SEE H6 & H11.
Patient problems: Aneurysm
MAUDE report 20850370 ↗InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE CLINICAL STUDY, RAGE: ON (B)(6) 2023, THE PARTICIPANT UNDERWENT FOLLOW-UP DSA. THE INVESTIGATOR IDENTIFIED RESIDUAL LEFT POSTERIOR COMMUNICATING ANEURYSM. ON (B)(6) 2023, THE PARTICIPANT PRESENTED TO THE HOSPITAL FOR PIPELINE FLOW DIVERSION OF PREVIOUSLY TREATED ANEURYSM. THE PATIENT WAS TRANSFERRED TO ICU FOR CLOSE MONITORING AND MEDICAL MANAGEMENT. THE EVENT WAS DETERMINED TO BE PROBABLY RELATED TO STUDY DEVICE AND POSSIBLY RELATED TO STUDY PROCEDURE. THE EVENT WAS RESOLVED WITHOUT SEQUELAE. EVENT TERM: RESIDUAL ANEURYSM. EVENT #: 6. EVENT START DATE: 23/MAR/2023. POST OPERATIVE DAYS: 343 DAYS.
Patient problems: Thrombosis/Thrombus
MAUDE report 20177515 ↗MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE 3RD COIL INTO A RUPTURED ACOMM ANEURYSM, RESISTANCE WAS ENCOUNTERED. THE COIL DETACHED WELL; HOWEVER, WHEN THE PHYSICIAN WITHDREW THE PUSHER WIRE, A VERY THIN FILAR APPEARED AT PROXIMAL END OF THE MICROCATHETER THAT EVENTUALLY BROKE OFF INSIDE THE MICROCATHETER. THE PUSHER WIRE AND MICROCATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED, AND THE COIL MASS LOOKED GOOD. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15547457 ↗MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING COIL EMBOLIZATION TO TREAT A RUPTURED ANEURYSM, THE EMBOLIZATION COIL DETACHED IN THE INTERNAL CAROTID ARTERY DURING RETRACTION. THE COIL REMAINS IMPLANTED. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11255491 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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