Cosmos 18 Advanced 8218-1243Recalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 18, 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 00811425028780), received between Oct 2, 2018 and Oct 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Separation Failure1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 2, 2018Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL WOULD NOT DETACH. DURING THE REMOVAL ATTEMPT, THE COIL DETACHED IN THE CATHETER. THE COIL WAS SUCCESSFULLY PUSHED THROUGH THE CATHETER INTO THE ANEURYSM; HOWEVER, A TAIL OF THE COIL EXTENDED INTO THE PARENT VESSEL. THE TAIL WAS AFFIXED TO THE VESSEL WALL WITH A STENT. THERE WAS NO REPORTED CLINICAL SEQUELAE AS A RESULT OF THE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7928904 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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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