V-Trak 8410-0515-A2Recalls & reported problems
Microvention, Inc. · HyperSoft 3D Advanced · Class 2 · Implant
All models of V-Trak (75)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816777021328), received between Oct 5, 2018 and May 11, 2023 — classified as 1 death, 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Premature Separation1
- Separation Failure1
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 11, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation
DeathOct 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE COIL, THE PUSHER BROKE. THE PUSHER WAS SUCCESSFULLY REMOVED WITH A SNARE AND STENT RETRIEVER DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7940149 ↗
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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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