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MicroPlex Cosmos 100618CSSR-VRecalls & reported problems

Microvention, Inc. · V-Trak · Class 2 · Implant

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 00810170013539), received between Apr 20, 2022 and Apr 20, 2022 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

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.

  • MalfunctionApr 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, AN EMBOLIZATION COIL IMPLANT DID NOT DETACH FROM THE DELIVERY PUSHER. IT WAS DECIDED TO REMOVE THE DEVICE, WHICH DETACHED UNEXPECTEDLY. THERE WAS NO REPORTED INTERVENTION OR INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14164479 ↗

Other DEVICE, NEUROVASCULAR EMBOLIZATION devices

All DEVICE, NEUROVASCULAR EMBOLIZATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.