June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
June 12, 2024Medical DevicesFDA
Atrium Medical Corporation recalls ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Hazard: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.