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SealPTFE™
VASCUTEK LTD · Model T8008PS · UDI-DI 05037881153285
DSY
Prescription
10
510(k) clearances
5,136
Adverse events (374 deaths)
86
Recalls
28
Facilities
Description
SEALPTFE Wrap with Unity Construction Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin Wall Straight Wrapped FULLY REINFORCED WITH A PTFE SUPPORT
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.