Barricade Coil System 900087Recalls & 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 00818053020865), received between Jul 10, 2020 and Jul 10, 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.
MalfunctionJul 10, 2020Premature Separation; Premature Separation
IT WAS REPORTED THAT: "THE CASE WAS A CAVERNOUS ICA WIDE NECK ANEURYSM MEASURING 8MMX 7MM AND THE NECK MEASURED 6MM. THE PHYSICIAN PLANNED TO DO A BALLOON ASSISTED COILING OF THE ANEURYSM. THE SUPPORT HARDWARE WAS 7F COOK LONG SHEATH FOLLOWED BY 6F FARGOMAX. THE COPERNIC 5X20 WAS TAKEN ALONG WITH VASCO 10MP WITH HYBRID 12/14 GUIDE WIRE. THE FIRST COIL WAS 9X30 COMPLEX FRAME FOLLOWED BY 8X30 HELICAL FILL COIL. CHECK ANGIO SHOWED ANEURYSM STILL FILLING AND THE PHYSICIAN OPTED TO USE HELICAL FILL 5X20 COIL. THE BALLOON WAS INFLATED AND THE COILING WAS IN PROGRESS DURING WHICH THE PHYSICIAN FELT A SNAP AND SAW THAT THE COIL HAD PREMATURELY DETACHED AND NO MOVEMENT WAS THERE. THE PHYSICIAN DEFLATED THE BALLOON AND TRIED TO GET THE VASCO ALONG WITH COIL BACK INTO THE GUIDE. DURING THIS PROCESS THE COIL CAME PROXIMAL TO GUIDE AND ONLY THE PUSH WIRE CAME OUT. SOME PART OF THE COIL WAS STILL HANGING FROM THE NECK OF THE ANEURYSM AND INTO THE ICA. THE PHYSICIAN OPTED TO LEAVE THE SAME AS IT IS."
Patient problems: Aneurysm
MAUDE report 10259640 ↗
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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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