V-Trak 7118-1243-A2Recalls & reported problems
Microvention, Inc. · HydroFrame 18 Advanced · Class 2 · Implant
All models of V-Trak (75)
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 00816777023988), received between Oct 31, 2024 and Oct 31, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use 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.
InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THROUGH THE RAGE CLINICAL STUDY, THE EMBOLIZATION COIL WAS USED TO TREAT A LEFT ICA ANEURYSM THAT MEASURED 13MM X 10MM X 13MM AND NECK SIZE OF 9MM. REPORTEDLY, COIL COMPACTION REPORTED POST IMPLANTATION AND THE SUBJECT UNDERWENT RETREATMENT WITH COILING. THE SUBJECT EXITED THE STUDY ON AUGUST 22, 2023 WITH NO ADDITIONAL ADVERSE EVENTS REPORTED. REPORTEDLY, A TOTAL OF 17 COILS WERE IMPLANTED IN INDEX PROCEDURE AND 9 COILS WERE IMPLANTED IN THE RETREATMENT PROCEDURE.
Patient problems: Aneurysm
MAUDE report 20584546 ↗
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- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 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.
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