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Barricade Coil System 900105Recalls & 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 00818053021046), received between Mar 7, 2019 and Mar 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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

  • Difficult or Delayed Positioning1
  • Difficult to Remove1
  • Entrapment of Device1

Patient problems

  • Aneurysm1
  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • MalfunctionMar 7, 2019Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove

    IT WAS REPORTED THAT: IT WAS PLANNED AS BALLOON ASSISTED PROCEDURE FOR IC-PC RECANALIZATION. AFTER PLACING 11TH COIL, THE PHYSICIANS DECIDE TO SWITCH TO STENT ASSISTED TECHNIQUE. THE BALLOON WAS RETREATED, AND THE STENT WAS PLACED THROUGH SL10 USING JAIL TECHNIQUE. THEN, THE PHYSICIANS STARTED TO USE BARRICADE COILS FOR FINISHING. WHEN THE PHYSICIAN WAS TO REPOSITION 16TH COIL, FEELING OF PUSHER WIRE WAS MISSED. THE COIL WAS UNRAVELED, AND HE COULD NOT WITHDRAW THE COILS THROUGH THE PUSHER WIRE. USING PROWLER SELECT PLUS AND GOOSE NECK SNARE, THE PHYSICIAN COULD RETREAT COIL WITH SL10. THERE WAS REMAINED PART OF UNRAVELED COIL OUT OF ANEURYSM, BUT IT WAS IN THE STENT. SO, THEY DECIDED TO FINISH PROCEDURE. ACCORDING TO THE PHYSICIANS, IT WAS PROCEDURE FOR RECANALIZATION AND STENT ASSISTED. PERHAPS THE COIL INTERFERED WITH STENT OR OTHER COILS. "

    Patient problems: Aneurysm; Patient Problem/Medical Problem

    MAUDE report 8400641 ↗

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Sources and updates

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