Optima Coil System
BALT USA LLC · Model OPTI2512BLK · UDI-DI 00810068568936
Description
The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-29 | MICROVENTION INC. | Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targete |
| 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. |
| 2025-04-17 | Cook Incorporated | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. |
| 2024-02-20 | Boston Scientific Corporation | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. T |
| 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 |
| 2023-08-24 | MICROVENTION INC. | Peripheral coil system detachable has a potential of unsealed pouch packaging. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2022-05-05 | Cook Incorporated | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| 2019-11-24 | Microvention, Inc. | The devices may be missing the implant coil. |
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