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SealPTFE™
VASCUTEK LTD · Model T4008ES · UDI-DI 05037881141237
DSY
Prescription
10
510(k) clearances
5,136
Adverse events (374 deaths)
86
Recalls
28
Facilities
Description
SEALPTFE Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin
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 should have been cal |
| 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 reintervention procedures, so In |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.