Cosmos 10 Advanced 8210-0522Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811425028278), received between Apr 13, 2016 and May 16, 2016 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Issue” (2 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 18, 2026.
Most reported problems
Device problems
- Device Issue2
- Detachment Of Device Component1
- Stretched1
Patient problems
- Aneurysm2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2016Stretched; Device Issue; Stretched; Device Issue
IT WAS REPORTED FROM (B)(4) DURING THE EMBOLIZATION TREATMENT OF AN ANEURYSM, THE COIL WAS DEPLOYED SUCCESSFULLY. UPON REMOVAL OF THE DELIVERY PUSHER IT WAS REPORTED TO STRETCH AND BREAK. CLOT DEVELOPED IN THE NECK OF THE ANEURYSM AND REOPRO WAS ADMINISTERED. THE PATIENT WAS REPORTED TO AWAKE WITHOUT DEFICIT AND WENT HOME CLINICALLY INTACT. MR PERFORMED 1 DAY POST TX SHOWED NO INFARCT.
Patient problems: Aneurysm
MAUDE report 5657568 ↗InjuryApr 13, 2016Detachment Of Device Component; Device Issue; Detachment Of Device Component; Device Issue
IT WAS REPORTED FROM (B)(6) THAT DURING TREATMENT OF A RUPTURED PCOM ANEURYSM WITH BALLOON REMODELING, THE COIL DID NOT DETACH WITH MULTIPLE ATTEMPTS. THE COIL WAS REMOVED AND ADDITIONAL COILS WERE DEPLOYED SUCCESSFULLY. HOWEVER THE PATIENT WAS REPORTED TO HAVE DIFFUSION HITS IN THE CORTEX. ADDITIONAL INFORMATION WAS INQUIRED, HOWEVER NO OTHER PATIENT STATUS WAS AVAILABLE.
Patient problems: Aneurysm
MAUDE report 5575514 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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