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Barricade Coil System 900070Recalls & 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818053020698), received between Jul 2, 2019 and Mar 14, 2020 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Premature Separation1

Patient problems

  • Aneurysm2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 14, 2020Premature Separation; Premature Separation

    IT WAS REPORTED THAT: "DOCTOR HAD PLANNED TO COIL BASILAR TOP ANEURYSM, AFTER PLACING THE MICROCATHETER, THE DOCTOR TOOK COMPLEX FRAMING 6X20 COIL THROUGH THE MICROCATHETER (VASCO10D MICROCATHETER). AFTER FORMING DESIRED FRAMING THE DOCTOR PUSHED THE COIL FURTHER TO ALIGN WITH THE CATHETER MARKER FOR DETACHING THE COIL, BUT THE COIL DETACHED INSIDE THE MICROCATHETER ITSELF BEFORE EVEN CONNECTING THE DETACHMENT CABLE TO DETACH THE COIL. THE COIL WAS HANGING OUT OF THE ANEURYSM WHICH WAS SNARED OUT IN BITS AND PIECES. COIL WAS COMPLETELY SNARED OUT SO NO INJURY TO THE PATIENT."

    Patient problems: Aneurysm

    MAUDE report 9832743 ↗
  • MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT: "DR. (B)(6) (INR) DECIDED TO DO A STENT ASSISTED COILING CASE OF ACOM ANEURYSM WITH OUR COILS. HE USED PCONUS DEVICE IN THIS CASE. FIRST TWO COILS HE DEPLOYED WERE BARRICADE COMPLAX FRAME 11-7 AND 8-27 AND THIS WAS THE THIRD COIL WHICH HE WAS DEPLOYING. IT WENT WELL IN THE MICRO CATHETER BUT IN SIDE THE ANEURYSM IT WAS NOT BEHAVING WELL SO PHYSICIAN DECIDED TO REPOSITION IT , WHILE TAKING OUT THE COIL FROM ANEURYSM, IT GET DETACHED AND ALMOST MORE THEN HALF OF THE COIL WAS OUT SIDE THE ANEURYSM. FURTHER, HE RETRIEVED THIS COIL WITH THE HELP OF SNARE AND DEPLOYED MICROPLEX COILS. HE WAS SURPRISED TO SEE THAT WITHOUT DETACHMENT HOW THE COIL CAN GET DETACHED. FINALLY HE COMPLETED THE PROCEDURE."

    Patient problems: Aneurysm

    MAUDE report 8753936 ↗

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Sources and updates

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