HyperSoft Advanced 8510-0102-A1Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812636022284), received between Aug 20, 2024 and Aug 20, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2024Separation Failure; Separation Failure
AS REPORTED: THE EYE ARTERY SEGMENT ANEURYSM WAS 3.8MM*2.7MM, AND THE FIRST COIL 3*6 WAS FILLED, FOLLOWED BY 2*3, 1.5*3 AND FINALLY, THE CLOSING COIL 1*2. AFTER THE CLOSING COIL WAS DELIVERED INTO THE ANEURYSM, THE COIL DETACHED. WHEN THE PUSHER WAS PULLED BACK, IT WAS FOUND THAT THE COIL DID NOT DETACH NORMALLY, AND MANY ATTEMPTS TO DETACH AFTERWARDS FAILED. WHEN THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL DETACHED IN THE MICROCATHETER. THE EMBOLIZATION WAS COMPLETED AFTER THE MICROCATHETER WAS RE-USED AND A NEW COIL 1*2 WAS USED FOR REPLACEMENT. PATIENT IS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008250 ↗
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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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