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MicroPlex Helical Regular 180520HC-R-V (UDI 00810170010583)Recalls & 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 00810170010583), received between Apr 20, 2016 and Apr 20, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionApr 20, 2016Break; Break

    IT WAS REPORTED FROM THE (B)(6) THAT DURING THE TREATMENT OF AN ANEURYSM, THE COIL BROKE WHILE TRYING TO PUT INTO THE MICROCATHETER. NO PATIENT HARM OR INJURY WAS REPORTED.

    Patient problems: Aneurysm

    MAUDE report 5588210 ↗

Other DEVICE, NEUROVASCULAR EMBOLIZATION devices

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