Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Cardiovascular · 21 CFR 870.3450
Recent MDR events
194 adverse event reports on file
- GORE-TEX® VASCULAR GRAFTFeb 24, 2026InjuryW. L. Gore & Associates, Inc.2017233-2026-07192
- GORE® PROPATEN® VASCULAR GRAFTFeb 23, 2026InjuryW. L. Gore & Associates, Inc.2017233-2026-07179
- CARBOFLODec 11, 2025MalfunctionBard Peripheral Vascular, Inc.2020394-2025-02162
- CARBOFLODec 11, 2025MalfunctionBard Peripheral Vascular, Inc.2020394-2025-02161
- ADVANTAJun 6, 2025MalfunctionAtrium Medical Corporation3011175548-2025-000005
- CARBOFLOJan 6, 2025MalfunctionBard Peripheral Vascular, Inc.2020394-2024-01944
- GRAFTS ADVANTA VXT W/GDSMar 7, 2024MalfunctionAtrium Medical Corporation3011175548-2024-00074
- IMPRA VASCULAR GRAFTFeb 15, 2024MalfunctionBard Peripheral Vascular, Inc.2020394-2024-00204
- GRAFTS ADVANTA VXT W/GDSJan 19, 2024MalfunctionAtrium Medical Corporation3011175548-2024-00012
- GRAFTS ADVANTA VXT W/GDSJan 18, 2024InjuryAtrium Medical Corporation3011175548-2024-00010
Event type breakdown
Recalls
17 recall events for this product code
- Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1951-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1954-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1958-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1962-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1964-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1993-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1994-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1995-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1996-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedJun 4, 2024
ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1997-2024 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
C.r. Bard, Inc.
COVINGTON, GA, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
W. L. Gore & Associates, Inc
FLAGSTAFF, AZ, US
Peca Labs, Inc.
Pittsburgh, PA, US
C.r. Bard, Inc.
MADISON, GA, US
Atrium Medical Corporation
Merrimack, NH, US
Isomedix Operations Inc.
Northborough, MA, US
Maquet Cardiovascular Llc
Wayne, NJ, US
510(k) clearances
21 clearances for this product code
- Impra, Inc.May 14, 2001
K004012 · IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
- Atrium Medical Corp.Mar 1, 2000
K000504 · ADVANTA SUPER SOFT GRAFT
- Atrium Medical Corp.Oct 1, 1999
K992958 · ADVANTA GRAFT (<6MM)
- W. L. Gore & Associates, Inc.Sep 8, 1999
K991683 · PTFE RINGED GORE-TEX VASCULAR GRAFT
- Atrium Medical Corp.Aug 20, 1999
K992441 · ADVANTA GRAFT
- Possis Medical, Inc.Feb 1, 1999
K984183 · PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
- Impra, Inc.Dec 15, 1998
K983769 · DISTAFLO BYPASS GRAFT
- Impra, Inc.May 7, 1998
K981076 · VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT