FDA Device Intelligence
HomeW. L. Gore & Associates, Inc. › GORE-TEX Vascular Graft

GORE-TEX Vascular Graft

W. L. Gore & Associates, Inc. · Model VT07010L · UDI-DI 00733132615971

DYFDSY Prescription
10
510(k) clearances
195
Adverse events (6 deaths)
17
Recalls
8
Facilities

Description

VG THIN WALL 7MM X 10CM LINED

Recalls

DateFirmReason
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
2024-05-03Atrium Medical CorporationComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.