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Barricade Coil System 900107Recalls & 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 00818053021060), received between Aug 18, 2023 and Aug 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT: "AT THE MOMENT OF OPENING THE BOX CONTAINING BARRICADE COIL 2X4 THE BAG WAS APART FROM THE SHEATH WHICH USUALLY CONTAINS THE COIL, MEANING THAT THE COIL WASN'T STERILE. HOWEVER, THE PRODUCT WAS REMOVED FROM ITS CASE BECAUSE IT WAS AN EMERGENCY AND THERE WERE NO MORE OF THESE PRODUCTS AT THAT TIME. WHEN THE COIL WAS INTRODUCED INTRO THE PATIENT, THE X-RAYS SHOWED THAT THERE WAS NO COIL, ONLY THE CARRIER WIRE WAS PRESENT. AS ONE USUALLY ADVANCES THE COIL UNTIL IT IS SEEN IN THE X-RAYS, AS THERE WAS NONE, IT WAS PUSHED AND THE CARRIER WIRE COLLIDED WITH THE ANEURYSM BUT IT DIDN'T RUPTURE IT." INCIDENT REPORT FORM RECEIVED FOR THIS COMPLAINT INDICATED NO PATIENT INJURY WAS SUSTAINED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17572780 ↗

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Sources and updates

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