Barricade Coil System 900116Recalls & 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
- 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 00818053021152), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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
- Stretched1
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.
MalfunctionFeb 22, 2018Stretched; Stretched
IT WAS REPORTED THAT DURING TREATMENT WITH BARRICADE COIL, "WHILE TAKING COIL INTO ANEURYSM, THE PHYSICIAN HAD TO WITHDRAW A LOOP OF THE COIL IN ORDER TO THAT IN INTO DESIRED PORTION OF ANEURYSM SAC, BUT INSTEAD OF COIL COMING OUT WITH A SLIGHT PULL, IT GOT STRETCHED AND BECAME AS A THREAD. AS THE PHYSICIAN WAS STRUGGLING TO PULL OUT THE ENTIRE COIL OUT, IT GOT DETACHED WITH DISTAL 2 LOOPS IN THE ANEURYSM AND REST COIL HANGING PROXIMALLY. THEN, FINALLY PHYSICIAN DECIDE TO RETRIEVE THE ENTIRE COIL WITH THE HELP OF STENT RETRIEVER. AFTER THE COMPLETE RETRIEVAL THE PROCEDURE WAS DONE WITH OTHER SIZE OF THE COIL."
Patient problems: Aneurysm
MAUDE report 7291209 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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