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Barricade Coil System 900128Recalls & 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 18, 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 00818053021275), received between Jun 18, 2019 and Jun 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

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.

  • MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT: "PROCEDURE - ANEURYSM COILING, PATHOLOGY - ACOM ANEURYSM, ACCESSORIES - VASCO 10 MH-MP, ECLIPSE 9. DURING AN ANEURYSM COILING CASE WITH BALLOON ASSISTANCE, BARRICADE HELICAL FINISH COIL 1X3 WAS TAKEN FOR DEPLOYMENT. COIL WAS PREPARED AS PER THE IFU & INTRODUCED INTO Y-ADAPTOR FOR FLUSH. SHRINK LOCK WAS REMOVED & COIL PUSH-WIRE WAS ADVANCED TO PUSH COIL THROUGH Y-ADAPTOR INTO MICRO-CATHETER FOR DEPLOYMENT. COIL WAS DEPLOYED IN ACOM ANEURYSM; HOWEVER, IT WAS NOT SATISFACTORY, SO PHYSICIAN RETRIEVED & AGAIN ATTEMPTED DEPLOYMENT. WHILE 1.5-2 CM COIL LENGTH WAS INSIDE ANEURYSM SUDDENLY CONTROL ON COIL PUSH WIRE WAS LOST. IT WAS OBSERVED THAT COIL HAD DETACHED PREMATURELY INSIDE THE MICRO CATHETER WITH APPROXIMATELY 1CM COIL LENGTH IN IT. AFTER SOME MANIPULATION COIL WAS PUSHED INTO ANEURYSM WITH HELP OF COIL PUSH WIRE, BUT PROXIMAL LOOPS WERE HANGING IN PARENT VESSEL. AFTER SOME TIME, COIL MOVED & GOT MISPLACED. IT WAS RETRIEVED SUCCESSFULLY WITH STENT RETRIEVER. CASE WAS COMPLETED BY PLACING ANOTHER COIL (COMPLEX FINISH 1.5X2) FOLLOWED BY IMPLANTING BABY LEO 2.5X25."

    Patient problems: Aneurysm; Patient Problem/Medical Problem

    MAUDE report 8710126 ↗

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Sources and updates

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