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MicroPlex Helical Soft 100410HC-S-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 00810170010149), received between Jun 14, 2016 and Jun 14, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of 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 Component1
  • Device Issue1

Patient problems

  • Aneurysm1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 14, 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 MICROCATHETER. THE ENTIRE SYSTEM WAS REMOVED. NO INTERVENTION WAS TAKEN. NO HARM OR INJURY WAS INCURRED DUE TO THIS INCIDENT.

    Patient problems: Aneurysm

    MAUDE report 5723626 ↗

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.