DSYFDA Class 2 · 21 CFR 870.3450 · implantable
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
198
Manufacturers
30
Flagged signals
19
Adverse-event reports
3,342
Code matrix
| FDA product code | DSY |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3450 |
| GMDN | — (crosswalk pending) |
| 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 | 2012 | 41 | 47.2 | 1,810 |
| Death | 2014 | 45 | 28.9 | 1,193 |
| Other | 2013 | 25 | 28.8 | 643 |
| Other | 2011 | 20 | 23.0 | 400 |
| Other | 2010 | 9 | 21.5 | 156 |
| Other | 2010 | 16 | 18.4 | 247 |
| Death | 2010 | 3 | 14.8 | 26 |
| Death | 2015 | 23 | 9.2 | 161 |
| Other | 2009 | 7 | 8.1 | 37 |
| Other | 2011 | 3 | 7.2 | 10 |
| Other | 2012 | 3 | 7.2 | 10 |
| Death | 2014 | 13 | 5.2 | 40 |
| Death | 2013 | 11 | 4.4 | 26 |
| Death | 2018 | 11 | 3.9 | 21 |
| Death | 2010 | 9 | 3.6 | 15 |
| Death | 2012 | 5 | 3.2 | 6 |
| Death | 2011 | 5 | 3.2 | 6 |
| Death | 2012 | 8 | 3.2 | 10 |
| Injury | 2016 | 5 | 2.6 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 3,342 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| W. L. Gore & Associates, Inc. | 23 | 2024 | — |
| Vascutek, Ltd. | 22 | 2025 | — |
| Atrium Medical Corp. | 16 | 2012 | — |
| Meadox Medicals, Div. Boston Scientific Corp. | 15 | 1997 | — |
| MAQUET Cardiovascular, LLC | 13 | 2016 | — |
| C.R. Bard, Inc. | 7 | 1996 | — |
| Shiley, Inc. | 5 | 1984 | — |
| Medtronic Vascular | 4 | 1991 | — |
| Carbomedics, Inc. | 3 | 1997 | — |
| Merit Medical Systems, Inc. | 3 | 2022 | — |
| Usci, Div. C.R. Bard, Inc. | 3 | 1977 | — |
| Sulzermedica | 3 | 2000 | — |
| Atrium Medical Corporation | 2 | 2024 | — |
| Cobe Laboratories, Inc. | 2 | 1986 | — |
| VERYAN MEDICAL LIMITED | 2 | 2006 | — |
| Bard Peripheral Vascular, Inc. | 2 | 2005 | — |
| Thoratec Laboratories Corp. | 1 | 2000 | — |
| Boston Scientific Corp | 1 | 2006 | — |
| JOTEC GmbH | 1 | 2003 | — |
| LeMaitre Vascular, Inc. | 1 | 2013 | — |
| Edwards Lifesciences, LLC | 1 | 2003 | — |
| Possis Medical, Inc. | 1 | 1999 | — |
| INTERVASCULAR SAS | 1 | 2011 | — |
| BOSTON SCIENTIFIC CORPORATION | 1 | 2012 | 0.14 |
| Pacesetter Systems | 1 | 1983 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) · Vascular Flow Technologies Limited510(k) · 2025-10-20
Gelweave Vascular Prostheses · Vascutek, Ltd.510(k) · 2025-02-27
Gelsoft Plus Vascular Prostheses · Vascutek, Ltd.510(k) · 2024-11-15
Advanta VXT Vascular Graft, Flixene Vascular Graft · Atrium Medical Corporation510(k) · 2024-03-28
GORE® PROPATEN® Vascular Graft · W. L. Gore & Associates, Inc.510(k) · 2024-03-01
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts · Peca Labs, Inc.510(k) · 2024-01-17
GORE® PROPATEN® Vascular Graft · W. L. Gore & Associates, Inc.510(k) · 2024-01-09
GORE® ACUSEAL Vascular Graft · W. L. Gore & Associates, Inc.510(k) · 2023-12-19
GORE® ACUSEAL Vascular Graft · W. L. Gore & Associates, Inc.510(k) · 2023-06-23
HeRO Graft · Merit Medical Systems, Inc.510(k) · 2022-08-15
exGraft, exGraft Carbon · Peca Labs510(k) · 2022-08-04
HeRO Graft, HeRO Adapter · Merit Medical Systems, Inc.510(k) · 2021-05-25
Vascutek Gelsoft Plus ERS Vascular Graft · Vascutek, Ltd.510(k) · 2021-04-06
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft · Peca Labs510(k) · 2020-12-11
exGraft, exGraft Carbon · Peca Labs510(k) · 2019-04-22
exGraft, exGraft Carbon ePTFE Vascular Grafts · Peca Labs510(k) · 2018-08-21
HeRO Graft · Merit Medical Systems, Inc.510(k) · 2017-11-30
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts · Vascutek, Ltd.510(k) · 2017-07-14
Gelweave Vascular Grafts · Vascutek, Ltd.510(k) · 2017-06-30
FUSION Vascular Graft · Maquet Cardiovascular, LLC510(k) · 2016-02-16
Spiral Flow Peripheral Vascular Graft · Vascular Flow Technologies, Ltd.510(k) · 2015-05-06
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT · Vascular Flow Technologies, Ltd.510(k) · 2014-11-20
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT · Vascular Flow Technologies, Ltd.510(k) · 2014-05-30
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT · Maquet Cardiovascular, LLC510(k) · 2013-11-14
GORE ACUSEAL VASCULAR GRAFT · W. L. Gore & Associates, Inc.510(k) · 2013-04-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.