HyperSoft Advanced 8510-0206Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 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 00811425027769), received between Mar 9, 2017 and Mar 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2017Separation Failure; Separation Failure
IT WAS REPORTED THAT AFTER PLACEMENT OF AN EMBOLIZATION COIL IN A LEFT POSTERIOR COMMUNICATING ARTERY WIDE NECK ANEURYSM, THE COIL DID NOT FULLY DETACH. THE COIL WAS SECURED IN THE LEFT INTERNAL CAROTID ARTERY WITH TWO (2) ADDITIONAL STENTS. THERE WAS NO REPORTED PATIENT INJURY RELATED TO THE HYPERSOFT COIL. THERE WERE NO FOCAL DEFICITS OBSERVED POST-OPERATIVELY AND AT THE 6-MONTH FOLLOW-UP EXAMINATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6394122 ↗
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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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