HyperSoft Advanced 8510-0308Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811425027844), received between May 17, 2016 and Jun 16, 2016 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).
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 Component3
- Device Issue3
Patient problems
- Aneurysm3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING AN EMBOLIZATION TREATMENT OF A VESSEL, THE COIL WAS MANIPULATED FOR A MORE DESIRABLE POSITION RESULTING IN STRETCHING. THE COIL PREMATURELY DETACHED FROM THE DELIVERY PUSHER AND WAS REMOVED SUCCESSFULLY USING AN ENDOVASCULAR SNARE. THE OUTCOME WAS REPORTED TO BE GOOD. NO HARM OR INJURY WAS INCURRED.
Patient problems: Aneurysm
MAUDE report 5730787 ↗InjuryJun 7, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING AN EMBOLIZATION TREATMENT OF A VESSEL, THE COIL DID NOT DETACH WITH MULTIPLE ATTEMPTS. UPON WITHDRAWAL, THE COIL DETACHED WITHIN THE MICROCATHETER. THE COIL WAS PUSHED TO THE INTENDED SITE SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE DOING FINE.
Patient problems: Aneurysm
MAUDE report 5704985 ↗MalfunctionMay 17, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING AN EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL PREMATURELY DETACHED WITHIN THE CATHETER DURING POSITIONING. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: Aneurysm
MAUDE report 5661529 ↗
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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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