HCGFDA Class 2 · 21 CFR 882.5950 · implantable
Device, Neurovascular Embolization
Device family · Neurology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
184
Manufacturers
15
Flagged signals
16
Adverse-event reports
21,834
Code matrix
| FDA product code | HCG |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| GMDN | 35378, 35379 |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2015 | 4 | 23.5 | 65 |
| Other | 2013 | 3 | 17.7 | 32 |
| Other | 2014 | 3 | 17.7 | 32 |
| Death | 2005 | 6 | 17.0 | 76 |
| Death | 2015 | 14 | 14.1 | 159 |
| Death | 2013 | 3 | 10.6 | 18 |
| Death | 2010 | 3 | 8.5 | 13 |
| Death | 2016 | 7 | 7.0 | 31 |
| Death | 2014 | 6 | 6.0 | 21 |
| Death | 2017 | 5 | 5.0 | 12 |
| Death | 2006 | 28 | 4.3 | 67 |
| Death | 2011 | 19 | 2.8 | 20 |
| Injury | 2014 | 6 | 2.6 | 7 |
| Injury | 2014 | 6 | 2.2 | 5 |
| Death | 2007 | 14 | 2.1 | 7 |
| Injury | 2008 | 48 | 2.1 | 45 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 21,834 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Microvention, Inc. | 32 | 2017 | — |
| Boston Scientific Corp | 11 | 2011 | — |
| Micro Therapeutics, Inc. | 11 | 2007 | — |
| Stryker Neurovascular | 11 | 2025 | — |
| PENUMBRA, INC. | 10 | 2023 | — |
| Target Therapeutics | 9 | 1996 | — |
| Codman & Shurtleff, Inc. | 7 | 2017 | — |
| Balt USA, LLC | 5 | 2026 | — |
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 4 | 2021 | — |
| Biocompatibles UK Limited | 3 | 2010 | — |
| MicroPort NeuroTech (Shanghai) Co., Ltd. | 3 | 2024 | — |
| Cook, Inc. | 2 | 2000 | — |
| Medos International SARL | 2 | 2022 | — |
| Spartan Micro, Inc. | 1 | 2018 | — |
| BIOSPHERE MEDICAL | 1 | 2000 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Optima Coil System (OptiOne Coil System) · Balt USA, LLC510(k) · 2026-01-27
Target Detachable Coil · Stryker Neurovascular510(k) · 2025-12-11
InZone IST Detachment System; IZDS Connecting Cable · Stryker Neurovascular510(k) · 2025-10-17
Optima Coil System (Optima Packing Coil System) · Balt USA, LLC510(k) · 2025-09-26
Numen Coil Embolization System; NumenFR Detachment System · MicroPort NeuroTech (Shanghai) Co., Ltd.510(k) · 2024-09-30
Optima Coil System (OptiBlock Line Extension) · Balt USA, LLC510(k) · 2024-09-27
Target Detachable Coils · Stryker Neurovscular510(k) · 2024-08-29
Numen Coil Embolization System; NumenFR Detachment System · MicroPort NeuroTech (Shanghai) Co., Ltd.510(k) · 2024-01-10
Axium Detachable Coil; Axium Prime Detachable Coil · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular510(k) · 2023-11-07
Penumbra LP Coil System · Penumbra, Inc.510(k) · 2023-10-25
Target Tetra Detachable Coils · Stryker Neurovascular510(k) · 2022-12-14
Optima Coil System · Balt USA, LLC510(k) · 2022-12-06
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems · Medos International SARL510(k) · 2022-07-14
InZone Detachment System · Stryker Neurovascular510(k) · 2021-11-16
Numen Coil Embolization System; NumenFR Detachment System · MicroPort NeuroTech (Shanghai) Co., Ltd.510(k) · 2021-09-01
Axium Detachable Coil; Axium Prime Detachable Coil · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular510(k) · 2021-07-07
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems · Medos International SARL510(k) · 2021-05-28
i-ED COIL System · Kaneka Medical America, LLC510(k) · 2021-03-26
i-ED COIL · Kaneka Pharma America, LLC510(k) · 2020-04-25
Optima Coil System · Balt USA, LLC510(k) · 2020-02-01
Penumbra LP Coil System · Penumbra, Inc.510(k) · 2019-11-20
Spartan eCoil System · Spartan Micro, Inc.510(k) · 2018-12-04
Wallaby Avenir Coil System · Wallaby Medical, Inc.510(k) · 2018-05-04
Penumbra Coil 400, Ruby Coil System, POD System · Penumbra, Inc.510(k) · 2018-04-17
Optima Coil System · Blockade Medical, LLC (D.B.A. Balt Usa)510(k) · 2018-02-18
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.