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Barricade Coil System 900104Recalls & 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

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 00818053021039), received between Jan 14, 2021 and Jan 14, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Slipped1

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.

  • MalfunctionJan 14, 2021Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

    IT WAS REPORTED THAT: "IN THE TREATMENT OF AN ANEURYSM'S BIFURCATION ON A FEMALE PATIENT AGED 60, AFTER THREE ATTEMPTS THE COIL DID NOT DEPLOY SO IT WAS DECIDED TO RETRIEVE IT BUT IT BROKE LEAVING A PART OF IT IN THE VESSEL, THEN IT WAS PUSHED WITH ANOTHER COIL BUT THE PREVIOUS ONE HAD LEFT OCCLUSION IN PART OF THE ARTERY BECAUSE THERE WAS NO CONTROL ON THE BROKEN COIL. DESPITE A BRANCH OF THE VESSEL WAS OCCLUDED IT WAS NOT REPORTED THAT THE PATIENT HAD SIGNIFICANT INJURY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11171849 ↗

Other Device, Neurovascular Embolization devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.