HyperSoft Advanced 8510-0308-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 00812636022475), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
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.
MalfunctionJul 15, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM OF THE MIDDLE CEREBRAL ARTERY, AN EMBOLIZATION COIL IMPLANT APPEARED LARGER THAN THE ACTUAL SPECIFICATION DURING PLACEMENT IN THE ANEURYSM. THE COIL WAS REMOVED AND A NEW COIL WAS SELECTED FOR PLACEMENT. THE ANGIOGRAPHIC EFFECT WAS SATISFACTORY, THE PROCEDURE WAS SUCCESSFULLY CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19745891 ↗
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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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