Barricade Coil System 900114Recalls & 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 00818053021138), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT: "ACOMA ANEURYSM WAS PLANNED USING BARRICADE COILS. VASCO 10 MICRO CATHETER WAS NAVIGATED INTO THE ANEURYSM OVER CHIKAI 14 GUIDE WIRE. FIRST COIL BARRICADE COMPLEX FRAME 4MM/13CMS WAS PREPARED AS PER IFU DEPLOYED AND DETACHED INTO THE ANEURYSM WITHOUT ANY DIFFICULTY. BARRICADE COMPLEX FINISH COIL 3MM/6CMS WAS TAKEN AS SECOND COIL, PREPARED AS PER IFU, THE COIL WAS COMING OUT OF THE ANEURYSM SAC HENCE WAS REPOSITIONED TWICE. WHILE TRYING TO REPOSITION FOR THIRD TIME THE COIL GOT DETACHED INTO THE MICRO CATHETER. THE COIL MIGRATED INTO THE MCA. WHILE ATTEMPTING TO REMOVING THE COIL WITH SOLITAIRE STENT. THE COIL BROKE HALFWAY INTO THE SOLITAIRE AND HALF INTO THE ICA. THE COIL LEFT IN THE ICA WAS PLASTERED WITH ATLAS STENT. NOTHING WAS DONE FURTHER."
Patient problems: Aneurysm
MAUDE report 9589374 ↗
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- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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