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MicroPlex Helical Regular 180520HC-R-V (UDI 00811425025963)Recalls & reported problems

Microvention, Inc. · V-Trak · Class 2

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 00811425025963), received between Oct 13, 2017 and Oct 13, 2017 — 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-Device Incompatibility1

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.

  • MalfunctionOct 13, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

    IT WAS REPORTED THAT DURING REPOSITIONING OF AN EMBOLIZATION COIL IN A CAROTID CAVERNOUS FISTULA, THE COIL "WAS NOT MOVING." DURING REMOVAL, THE COIL STRETCHED AND UNEXPECTEDLY DETACHED IN THE FISTULA. BOTH SEGMENTS OF THE COIL WERE REMOVED ALONG WITH THE MICROCATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE DOING WELL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6950319 ↗

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.