MicroPlex Cosmos 181652CS-VRecalls & reported problems
Microvention, Inc. · V-Trak · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810170014147), received between Mar 21, 2019 and Aug 16, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Difficult or Delayed Positioning1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL, THE IMPLANT COIL DETACHED PREMATURELY WITHOUT USE OF THE CONTROLLER. THE COIL WAS RETRIEVED WITH DIFFICULTY WITH A MICROSNARE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8902408 ↗MalfunctionMar 21, 2019Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING ADVANCEMENT OF THE FIFTH EMBOLIZATION COIL INTO A LEFT INTERNAL CAROTID CAVERNOUS FISTULA, SEVERE RESISTANCE WAS ENCOUNTERED. DURING THE ATTEMPT TO REMOVAL THE COIL, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED IN ITS ENTIRETY TOGETHER WITH THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED A COUPLE DAYS POST PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8441611 ↗
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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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