Barricade Coil System 900100Recalls & 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 00818053020995), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
- Premature Separation1
Patient problems
- Embolism/Embolus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2021Migration; Premature Separation; Migration; Premature Separation
IT WAS REPORTED THAT: "THE PHYSICIAN WHILE TREATING A RUPTURED LEFT ANTERIOR CHOROIDAL ARTERY ANEURYSM, GOT ACCESS USING 7FR LONG SHEATH AND FARGOMAX 105. ACCESSED THE ANEURYSM WITH VASCO 10 MICROCATHETER AND TRAXCESS WIRE. USED ECLIPSE 2L BALLON AS BACKUP SINCE THE ANEURYSM IS RUPTURED ONE.. AFTER ACCESSING THE ANEURYSM STARTED DEPLOYING COILS. USED 6 BARRICADE COILS OF DIFFERENT SIZES. AFTER THAT TOOK DSA AND FOUND THAT THERE IS SOME MORE SPACE TO BE FILLED FOR GETTING A COMPLETE OCCLUSION OF THE ANEURYSM. SO, THE PHYSICIAN DECIDED TO USE BARRICADE HELICAL FINISH 4 X 10 AS THE LAST COIL. WITHOUT ANY ISSUES THE COIL PASSED THROUGH THE CATHETER INTO THE ANEURYSM. AFTER COUPLE OF LOOPS (ALMOST HALF OF THE LENGTH OF THE COIL) WHILE TRYING TO PUSH THE COIL, THE PHYSICIAN NOTICED THAT THE COIL PUSHER WIRE IS FREELY MOVING, BUT THERE IS NO MOVEMENT TO THE COIL. PHYSICIAN SLOWLY TRIED TO PULL BACK THE PUSHER WIRE AT THAT TIME TOO THE WIRE IS COMING BACK FREELY WITH NO INTERACTION WITH THE COIL AND CONFIRMED THAT THE COIL GOT PREMATURE DETACHMENT WITHIN THE MICRO CATHETER ITSELF. AFTER THAT PHYSICIAN SLOWLY PULLED BACK THE MICRO. WHILE DOING THAT THE ENTIRE COIL MASS WAS ALSO MOVING AND A
Patient problems: Embolism/Embolus
MAUDE report 12128560 ↗
Other Device, Neurovascular Embolization devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page