Home › Device types › KRD
Device, Vascular, For Promoting Embolization
FDA product code KRD · Class 2 · Cardiovascular
6,709
Registered devices
14,678
Adverse events
20
Recalls
133
510(k) clearances
Devices with this code
HydroSoft Advanced — Microvention, Inc.Optima Coil System (OptiOne Coil System) — BALT USA LLCPrestige Coil System — BALT USA LLCPolyvinyl Alcohol Embolic Microspheres — Canyon Medical Inc.Numen Helia — MicroPort NeuroTech (Shanghai) Co., Ltd.DELTAMAXX CERECYTE — Medos International SàrlEmbozene® — BOSTON SCIENTIFIC CORPORATIONTARGET XL — Stryker CorporationNumen Helia — MicroPort NeuroTech (Shanghai) Co., Ltd.HydroSoft Advanced — Microvention, Inc.Tornado — COOK INCORPORATEDOptima Coil System — BALT USA LLCOptima Coil System — BALT USA LLCAxium Prime Detachable Coil System — Micro Therapeutics, Inc.Axium — Micro Therapeutics, Inc.CONCERTO VERSA™ — Micro Therapeutics, Inc.TARGET — Stryker CorporationOptima Coil System — BALT USA LLCAxiumTM — Micro Therapeutics, Inc.MicroPlex Helical Soft — Microvention, Inc.Avenir Mega Coil System — Shanghai Wallaby Medical Technologies Co., Inc.Optima Coil System (OptiOne Coil System) — BALT USA LLCAxium PrimeTM — Micro Therapeutics, Inc.HydroFill Advanced — Microvention, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-10 | Merit Medical Systems, Inc. | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the |
| 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. |
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