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Device, Neurovascular Embolization
FDA product code HCG · Class 2 · Neurology
0
Registered devices
26,296
Adverse events
68
Recalls
187
510(k) clearances
Devices with this code
Optima Coil System (OptiOne Coil System) — BALT USA LLCOptima Coil System — BALT USA LLCNumen Helia — MicroPort NeuroTech (Shanghai) Co., Ltd.DELTAMAXX CERECYTE — Medos International SàrlTARGET XL — Stryker CorporationNumen Helia — MicroPort NeuroTech (Shanghai) Co., Ltd.MicroPlex Helical Regular — Microvention, Inc.MicroPlex Cosmos — Microvention, Inc.MicroPlex Helical Regular — Microvention, Inc.POD — PENUMBRA, INC.Optima Coil System — BALT USA LLCOptima Coil System — BALT USA LLCAxium Prime Detachable Coil System — Micro Therapeutics, Inc.GDC-18 — Stryker CorporationTARGET — Stryker CorporationOptima Coil System — BALT USA LLCAxiumTM — Micro Therapeutics, Inc.Avenir Mega Coil System — Shanghai Wallaby Medical Technologies Co., Inc.DELTAPAQ CERECYTE — Medos International SàrlOptima Coil System (OptiOne Coil System) — BALT USA LLCHydroSoft Helical — Microvention, Inc.MATRIX2 — Stryker CorporationAxium PrimeTM — Micro Therapeutics, Inc.Barricade Coil System — BALT USA LLC
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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