Home › Device types › DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
FDA product code DSY · Class 2 · Cardiovascular
3,682
Registered devices
5,173
Adverse events
87
Recalls
188
510(k) clearances
Devices with this code
Hemagard — INTERVASCULAR SASGORE ACUSEAL Vascular Graft — W. L. Gore & Associates, Inc.Intergard — INTERVASCULAR SASIMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular, Inc.IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular, Inc.taperflo™ — VASCUTEK LTDMAXIFLO™ — VASCUTEK LTDLifeSpan ePTFE Vascular Graft — Lemaitre Vascular, Inc.Intergard — INTERVASCULAR SASGelseal™ — VASCUTEK LTDSealPTFE™ — VASCUTEK LTDMAXIFLO™ — VASCUTEK LTDExxcel Soft ePTFE Vascular Graft — MAQUET CARDIOVASCULAR LLCMAXIFLO™ — VASCUTEK LTDVP1200K™ — VASCUTEK LTDGORE-TEX Stretch Vascular Graft-Bifurcated — W. L. Gore & Associates, Inc.Gelweave Vascular Prostheses — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDADVANTA SLIDER GDS — Atrium Medical CorporationSealPTFE™ — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDIMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-12 | INTERVASCULAR, SAS | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). |
| 2025-12-18 | Vascutek, Ltd. | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry |
| 2025-08-26 | W L Gore & Associates, Inc. | Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reinterventi |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| 2024-05-03 | Atrium Medical Corporation | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
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