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Device, Neurovascular Embolization
FDA product code HCG · Class 2 · Neurology
5,145
Registered devices
26,211
Adverse events
68
Recalls
187
510(k) clearances
Devices with this code
ORBIT GALAXY ENPOWER — Medos International SàrlAxium™ Prime Detachable Coil System — Micro Therapeutics, Inc.Axium™ Prime Detachable Coil System — Micro Therapeutics, Inc.RUBY Coil — PENUMBRA, INC.Smart Coil — PENUMBRA, INC.Smart Coil — PENUMBRA, INC.Numen — MicroPort NeuroTech (Shanghai) Co., Ltd.CASHMERE CERECYTE — Medos International SàrlMicroPlex Helical Regular — Microvention, Inc.Numen — MicroPort NeuroTech (Shanghai) Co., Ltd.HELIPAQ CERECYTE — Medos International SàrlAxium Prime Detachable Coil System — Micro Therapeutics, Inc.MicroPlex Helical Regular — Microvention, Inc.i-ED COIL — KANEKA CORPORATIONAxium PrimeTM — Micro Therapeutics, Inc.V-Trak — Microvention, Inc.Axium™ Detachable Coil System — Micro Therapeutics, Inc.GDC-10 — Stryker CorporationEmbosphere® — BIOSPHERE MEDICALGALAXY G3 — Medos International SàrlHydroCoil Helical — Microvention, Inc.MicroPlex Cosmos — Microvention, Inc.MicroPlex Helical Regular — Microvention, Inc.DELTAPAQ CERECYTE — Medos International Sàrl
Recent 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 visua |
| 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 interv |
| 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 |
| 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 |
| 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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