HydroSoft 3D 7110-0154-3D-A2Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
All models of HydroSoft 3D (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777025357), received between Oct 24, 2019 and May 6, 2023 — classified as 1 injury, 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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH A RAGE CLINICAL STUDY, ON (B)(6) 2020, THE PATIENT RECEIVED RE-TREATMENT FOR CEREBRAL ANEURYSM THAT WAS ORIGINALLY EMBOLIZATION ON (B)(6) 2018 WITH THE USE OF SEVEN COILS. THE PATIENT REQUIRED RECOILING DUE TO COIL COMPACTION. DIAGNOSTIC PROCEDURES WERE PERFORMED BY USING A BALLOON TO ASSIST THE COILING. THE RECOILING RESULTS SHOWED THERE WAS A GOOD FILLING OF THE ANEURYSM WITH A COIL MASS AND PROTECTION OF THE DOME. AFTER THE PROCEDURE, THE PATIENT WAS AWOKEN FROM ANESTHESIA AND WAS NEUROLOGICALLY STABLE. THE PATIENT WAS TRANSFERRED TO THE NEUROCRITICAL CARE UNIT FOR CLOSE MONITORING. THE PATIENT WILL REMAIN ON DUAL ANTIPLATELET THERAPY FOR 4 TO 6 WEEKS AND AFTER WILL BE PRESCRIBED BABY ASPIRIN FOR LIFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16883091 ↗MalfunctionOct 24, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT COIL EMBOLIZATION WAS PERFORMED ON A CAVERNOUS CAROTID FISTULA USING VENOUS ACCESS. DURING REPOSITIONING, THE COIL STRETCHED AND DETACHED. THE COIL WAS LEFT IN THE VEIN AND THE PUSHER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL INTERVENTION. THE PATIENT IS REPORTED TO BE "FINE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9236110 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page