NRYFDA Class 2 · 21 CFR 870.1250
Catheter, Thrombus Retriever
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
106
Manufacturers
16
Flagged signals
16
Adverse-event reports
8,191
Code matrix
| FDA product code | NRY |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| 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 |
|---|---|---|---|---|
| Death | 2012 | 6 | 17.5 | 78 |
| Death | 2012 | 6 | 8.3 | 32 |
| Death | 2011 | 44 | 7.0 | 222 |
| Death | 2012 | 35 | 5.6 | 128 |
| Death | 2013 | 4 | 5.5 | 11 |
| Death | 2024 | 6 | 4.4 | 13 |
| Death | 2015 | 13 | 4.0 | 27 |
| Death | 2017 | 12 | 3.7 | 21 |
| Death | 2019 | 9 | 3.6 | 15 |
| Death | 2015 | 18 | 2.9 | 20 |
| Death | 2021 | 7 | 2.8 | 7 |
| Other | 2010 | 16 | 2.8 | 17 |
| Death | 2023 | 11 | 2.7 | 10 |
| Death | 2013 | 16 | 2.5 | 14 |
| Death | 2022 | 28 | 2.3 | 19 |
| Death | 2024 | 26 | 2.1 | 14 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 8,191 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| PENUMBRA, INC. | 24 | 2025 | — |
| Concentric Medical, Inc. | 16 | 2015 | — |
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 11 | 2024 | — |
| IMPERATIVE CARE, INC. | 7 | 2025 | — |
| Alembic, LLC | 6 | 2025 | — |
| Cerenovus, Inc. | 4 | 2025 | — |
| Route 92 Medical, Inc. | 3 | 2025 | — |
| Inneuroco, Inc. | 3 | 2019 | — |
| Wallaby Medical | 2 | 2024 | — |
| Stryker | 2 | 2019 | — |
| Microvention, Inc. | 2 | 2022 | — |
| Stryker Neurovascular | 2 | 2019 | — |
| Balt USA, LLC | 2 | 2025 | — |
| Codman & Shurtleff, Inc. | 1 | 2020 | — |
| NEURAVI LIMITED | 1 | 2025 | — |
| Scientia Vascular, Inc. | 1 | 2023 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Millipede System · Perfuze, Ltd.510(k) · 2026-03-16
Tigertriever 25 Revascularization Device · Rapid Medical , Ltd.510(k) · 2026-03-12
Esperance pHLO Aspiration System · Phenox, Ltd.510(k) · 2026-01-15
NeVasc Aspiration System · Vesalio, Inc.510(k) · 2025-11-10
Zoom System (Zoom 4S Catheter) · Imperative Care, Inc.510(k) · 2025-10-30
Tigertriever 17 Ultra Revascularization Device · Rapid Medical , Ltd.510(k) · 2025-10-06
EMBOTRAP III Revascularization Device · Neuravi Limited510(k) · 2025-09-25
Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set · Perfuze, Ltd.510(k) · 2025-08-29
CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set · Cerenovus, Inc.510(k) · 2025-08-22
Raptor Aspiration Catheter; Balt Aspiration Tubing Set · Balt USA, LLC510(k) · 2025-06-03
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing · Imperative Care, Inc.510(k) · 2025-05-28
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set · Route 92 Medical, Inc.510(k) · 2025-05-19
APRO 45 Catheter and Alembic Aspiration Tubing · Alembic, LLC510(k) · 2025-04-30
APRO 55 Swift Catheter and Alembic Aspiration Tubing · Alembic, LLC510(k) · 2025-04-28
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set · Perfuze, Ltd.510(k) · 2025-02-26
APRO 70 Swift Catheter and Alembic Aspiration Tubing · Alembic, LLC510(k) · 2025-02-24
Penumbra System (Reperfusion Catheter RED 72) · Penumbra, Inc.510(k) · 2025-02-13
Zoom System · Imperative Care, Inc.510(k) · 2025-01-14
Riptide Aspiration System · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular510(k) · 2024-10-29
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set · Cerenovus, Inc.510(k) · 2024-10-16
Esperance 3+ Aspiration Catheter System · Wallaby Medical510(k) · 2024-10-01
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set · Perfuze, Ltd.510(k) · 2024-09-20
Next Generation Aspiration Catheter; Balt Aspiration Tubing Set · Balt USA, LLC510(k) · 2024-07-02
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set · Route 92 Medical, Inc.510(k) · 2024-04-23
APRO 55 Catheter and Alembic Aspiration Tubing · Alembic, LLC510(k) · 2024-02-29
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.