Home › Device types › DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
FDA product code DSY · Class 2 · Cardiovascular
3,676
Registered devices
5,136
Adverse events
86
Recalls
188
510(k) clearances
Devices with this code
Gelsoft Plus™ — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDADVANTA SLIDER GDS — Atrium Medical CorporationGORE-TEX Vascular Graft — W. L. Gore & Associates, Inc.LifeSpan ePTFE Vascular Graft — Lemaitre Vascular, Inc.Gelweave™ — VASCUTEK LTDMAXIFLO™ — VASCUTEK LTDGelweave™ — VASCUTEK LTDGelweave™ — VASCUTEK LTDSealPTFE™ — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDGORE PROPATEN Vascular Graft — W. L. Gore & Associates, Inc.SealPTFE™ — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDGelweave™ — VASCUTEK LTDMAXIFLO™ — VASCUTEK LTDExxcel Soft ePTFE Vascular Graft — MAQUET CARDIOVASCULAR LLCGelweave™ — VASCUTEK LTDIntergard — INTERVASCULAR SASLifeSpan ePTFE Vascular Graft — Lemaitre Vascular, Inc.Gelweave Vascular Prostheses — VASCUTEK LTDGelweave Vascular Prostheses — VASCUTEK LTDIMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular, Inc.Gelweave Vascular Prostheses — VASCUTEK LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 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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