V-Trak 8410-0408-A2Recalls & reported problems
Microvention, Inc. · HyperSoft 3D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816777021304), received between Oct 28, 2018 and Oct 28, 2018 — classified as 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
- Detachment of Device or Device Component1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2018Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE THIRD ATTEMPT TO REPOSITION THE EMBOLIZATION COIL IN THE ANEURYSM, THE COIL STRETCHED AND THEN DETACHED. THE ENTIRE COIL WAS REMOVED FROM THE ANEURYSM BY ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING WELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8011779 ↗
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- 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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