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MAXIFLO™
VASCUTEK LTD · Model T1008P · UDI-DI 05037881151984
DSY
Prescription
10
510(k) clearances
5,173
Adverse events (375 deaths)
87
Recalls
28
Facilities
Description
MAXIFLO ePTFE Vascular Prosthesis Wrap with Unity Construction ULTRATHIN WALL STRAIGHT WRAPPED, FULLY REINFORCED WITH A PTFE SUPPORT.
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 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. |
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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.