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Barricade Coil System 900013Recalls & reported problems

Balt USA LLC · Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The BCS consists of an implantable coil attached to a delivery pusher. The delivery pusher is powered by the Blockade Detachment Controller (BDC) designed specifically for the BCS. The device comes pre-loaded with one 9-volt battery. A BlockWire Connecting Cable or Handheld Detachment Cable, comprised of a red and black cable leads are required to detach Barricade Detachable Coils and must be used in conjunction with a return electrode. · Class 2 · Implant

All models of Barricade Coil System (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00818053020148), received between May 8, 2018 and May 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device1

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.

  • MalfunctionMay 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT A "1MM X 1CM COMPLEX FINISH COIL WAS USED AS 2ND COIL UNDER THE BALLOON ASSISTED BUT THE COIL COULD NOT BE DETACHED THOUGH THE SURGEON TRIED DETACHMENT AT 3 TIMES. THEN, THE COIL WAS REMOVED AND OTHER COIL OF THE SAME SIZE WAS USED AND DETACHED AND PLACED IN PROPERLY. IT WAS REPORTED THAT THE COIL (MAYBE BARRICADE COIL) WAS MIGRATED TO NEAR MCA (M3) UNINTENTIONALLY AND THE BLEEDING WAS ALSO OBSERVED AT M2 SEGMENT DURING WITHDRAWING THE MIGRATED COIL (SUBARACHNOID HEMORRHAGE WAS DEVELOPED). THIRD COIL (BARRICADE COIL) WAS DETACHED PROPERLY AFTER THE SURGEON INSERTED THE NEEDLE DEEPER. THEREFORE, THE SURGEON GUESS THAT THE DEPTH OF THE NEEDLE MIGHT HAVE RESULTED IN THIS DETACHMENT ERROR. THE SURGEON ALSO COMMENTED THAT THERE IS NO RELATION BETWEEN DETACHMENT ERROR AND MIGRATION OF THE COIL. (3RD COIL MIGHT HAD NOT GOT TWINE AROUND WITH 1ST COIL ENOUGH)."

    Patient problems: Aneurysm

    MAUDE report 7495676 ↗

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Sources and updates

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