Barricade Coil System 900123Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818053021220), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
Patient problems
- Aneurysm1
- Death1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT A "COIL WAS PREPARED AS PER THE IFU AND PUSHED INSIDE MICRO CATHETER. BARRICADE COMPLEX FINISH 5X8 COIL WAS DEPLOYED IN ATOM ANEURYSM. AFTER COMPLETE COIL DEPLOYMENT PHYSICIAN WAITED FOR 10 MINUTES TO TAKE CHECK SHOOT BEFORE DETACHMENT. IN CHECK SHOOT IT WAS OBSERVED THAT OPPOSITE A2 WAS NOT FILLING SO PHYSICIAN DECIDED TO RETRIEVE THE COIL. WHILE RETRIEVING COIL IT GOT PREMATURELY DETACHED INSIDE MICRO CATHETER. COIL WAS LEFT LIKE THAT & CASE WAS ABANDONED SINCE 70% OF COIL REMAINED INSIDE ANEURYSM & 30% IN VESSEL. PATIENT KEPT ON VENTILATOR POST CASE".
Patient problems: Aneurysm; Death; Patient Problem/Medical Problem
MAUDE report 7744112 ↗
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- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
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- 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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