Barricade Coil System
BALT USA LLC · Model 900063 · UDI-DI 00818053020643
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | Stryker Neurovascular | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be |
| 2025-10-02 | Cerenovus Inc | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. |
| 2025-05-08 | BALT USA, LLC | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| 2024-01-03 | BALT USA, LLC | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of sold |
| 2022-09-07 | BALT USA, LLC | Product pouch label does not match up with carton label |
| 2022-07-26 | BALT USA, LLC | Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier. |
| 2022-04-27 | Micro Therapeutics, Inc. | Due to incorrect size and configuration labeling of the detachable coil system. |
| 2022-01-04 | BALT USA, LLC | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mi |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
| 2019-11-22 | Microvention, Inc. | The devices may be missing the implant coil. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs