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Device, Vascular, For Promoting Embolization
FDA product code KRD · Class 2 · Cardiovascular
6,607
Registered devices
14,423
Adverse events
19
Recalls
132
510(k) clearances
Devices with this code
Cosmos 10 Advanced — Microvention, Inc.ORBIT GALAXY ENPOWER — Medos International SàrlPolyvinyl Alcohol Embolic Microspheres — Canyon Medical Inc.Axium™ Prime Detachable Coil System — Micro Therapeutics, Inc.Axium™ Prime Detachable Coil System — Micro Therapeutics, Inc.MReye — COOK INCORPORATEDNester — COOK INCORPORATEDPrestige Coil System — BALT USA LLCNumen — MicroPort NeuroTech (Shanghai) Co., Ltd.Axium Prime Detachable Coil System — Micro Therapeutics, Inc.HydroSoft Advanced — Microvention, Inc.Numen — MicroPort NeuroTech (Shanghai) Co., Ltd.Prestige Coil System — BALT USA LLCRUBY Coil — PENUMBRA, INC.Axium Prime Detachable Coil System — Micro Therapeutics, Inc.Prestige Coil System — BALT USA LLCi-ED COIL — KANEKA CORPORATIONPolyvinyl Alcohol Embolic Microspheres — Canyon Medical Inc.Axium PrimeTM — Micro Therapeutics, Inc.ConcertoTM — Micro Therapeutics, Inc.V-Trak — Microvention, Inc.Azur Detachment Controller — Microvention, Inc.Axium™ Detachable Coil System — Micro Therapeutics, Inc.GDC-10 — Stryker Corporation
Recent 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 l |
| 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 |
| 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 |
| 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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