DWFFDA Class 2 · 21 CFR 870.4210
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
401
Manufacturers
48
Flagged signals
17
Adverse-event reports
4,596
Code matrix
| FDA product code | DWF |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| 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 |
|---|---|---|---|---|
| Other | 2015 | 8 | 95.0 | 654 |
| Other | 2012 | 5 | 59.4 | 232 |
| Other | 2010 | 4 | 47.5 | 139 |
| Other | 2014 | 4 | 47.5 | 139 |
| Other | 2011 | 3 | 35.6 | 69 |
| Death | 2023 | 6 | 7.2 | 26 |
| Death | 2015 | 6 | 7.2 | 26 |
| Death | 2016 | 6 | 7.2 | 26 |
| Death | 2022 | 5 | 5.2 | 13 |
| Death | 2025 | 6 | 5.0 | 16 |
| Death | 2021 | 6 | 5.0 | 16 |
| Death | 2017 | 4 | 4.8 | 9 |
| Death | 2016 | 4 | 4.2 | 7 |
| Death | 2024 | 4 | 3.4 | 5 |
| Death | 2021 | 7 | 2.9 | 7 |
| Death | 2014 | 6 | 2.5 | 4 |
| Death | 2015 | 6 | 2.5 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 4,596 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Medtronic, Inc. | 31 | 2026 | — |
| Dlp, Inc. | 22 | 1996 | — |
| Shiley, Inc. | 21 | 1990 | — |
| 3M Health Care, Sarns | 21 | 1994 | — |
| Edwards Lifesciences, LLC | 18 | 2020 | — |
| Sorin Group Italia S.r.L. | 12 | 2026 | — |
| MEDTRONIC PERFUSION SYSTEMS | 12 | 2009 | — |
| Sherwood Medical Co. | 10 | 1988 | — |
| CARDIACASSIST, INC. | 9 | 2018 | — |
| Terumo Cardiovascular Systems Corp. | 8 | 2014 | — |
| Quest Medical, Inc. | 8 | 2000 | — |
| Maquet Cardiopulmonary, AG | 7 | 2014 | — |
| C.R. Bard, Inc. | 6 | 1993 | — |
| Medtronic Vascular | 6 | 2004 | — |
| Angiodynamics, Inc. | 4 | 2025 | — |
| Terumo Cardiovascular Systems Corporation | 2 | 2015 | — |
| Uresil Corp. | 2 | 1987 | — |
| LIVANOVA USA, INC. | 2 | 2026 | — |
| Thoratec Corporation | 2 | 2015 | — |
| Quinton, Inc. | 2 | 1989 | — |
| American Bentley | 2 | 1985 | — |
| Medsurg Industries, Inc. | 2 | 1988 | — |
| Gish Biomedical, Inc. | 2 | 2009 | — |
| Toray Industries (America), Inc. | 2 | 1987 | — |
| Cobe Cardiovascular, Inc. | 2 | 2001 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae · Medtronic, Inc.510(k) · 2026-04-23
Venous Return Cannulae · LivaNova USA, Inc.510(k) · 2026-03-11
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) · Smart Reactors510(k) · 2026-02-23
Retrograde Coronary Sinus Perfusion Cannulae · Medtronic, Inc.510(k) · 2026-02-19
Dual Stage Venous Cannulae · Sorin Group Italia S.R.L.510(k) · 2026-01-30
Clearview Intracoronary Shunts · Medtronic, Inc.510(k) · 2026-01-20
AngioVac Cannula · AngioDynamics, Inc.510(k) · 2025-10-24
RAP Femoral Venous Cannulae · LivaNova USA, Inc.510(k) · 2025-07-10
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) · Sorin Group Italia S.R.L.510(k) · 2025-06-27
MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula · Medtronic, Inc.510(k) · 2025-06-20
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) · Spectrum Medical S.R.L.510(k) · 2024-05-31
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) · Sorin Group Italia S.R.L.510(k) · 2024-02-22
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); · Edwards Lifesciences510(k) · 2024-02-05
DLP Silicone Coronary Artery Ostial Cannulae · Medtronic, Inc.510(k) · 2023-12-07
DLP Silicone Coronary Artery Ostial Cannulae · Medtronic, Inc.510(k) · 2023-05-04
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS · Qura S.R.L510(k) · 2022-08-18
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set · Qura S.R.L510(k) · 2022-05-20
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F · Qura S.R.L510(k) · 2021-11-08
AngioVac F18 85 · AngioDynamics, Inc.510(k) · 2021-09-30
Bio-Medicus Life Support Catheter and Introducer · Medtronic, Inc.510(k) · 2021-07-15
Quantum Perfusion Arterial Cannula Graft · Qura S.R.L510(k) · 2021-06-30
Michler-Kapp Cardiovascular Vent Catheter · Kapp Surgical Instrument, Inc.510(k) · 2021-01-28
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line · Sorin Group Italia S.R.L.510(k) · 2020-11-17
QuickDraw Venous Cannula · Edwards Lifesciences, LLC510(k) · 2020-03-29
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula · Edwards Lifesciences, LLC510(k) · 2020-03-13
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.