Optima Coil System
BALT USA LLC · Model OPTI0713CST10 · UDI-DI 00818053026331
Description
The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated 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 embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.
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. |
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