FDA (Devices) recall action 94614
The FDA (Devices) publishes a recall like this one as 68 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 68 pages.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
The agency’s own wording, quoted from the enforcement report.
Atrium Medical Corporation is recalling approximately 53,308 FLIXENE vascular graft units worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating gaps that could affect device performance.
Atrium Medical Corporation recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units are affected worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall affects 53,308 units distributed worldwide.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation between the Slider GDS Swivel Rod and Swivel Core, affecting 53,308 units distributed worldwide.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core. The separation could affect device function during vascular procedures.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from its core component. This mechanical failure could compromise device functionality.
Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.
Atrium Medical Corporation has recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the pieces.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall affects 53,308 units distributed worldwide.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of internal components. The defect affects over 53,000 units distributed worldwide.
ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units worldwide are affected.
Atrium Medical Corporation recalls FLIXENE vascular grafts due to separation of the slider swivel rod from the core assembly. The device defect affects 53,308 units distributed worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.
Atrium Medical Corporation is recalling its ADVANTA VXT vascular graft due to reports that the Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between components.
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.
Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.
Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.
Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.
Atrium Medical's ADVANTA VXT vascular grafts are recalled due to reported separation of the slider component from the swivel core. Over 53,000 units worldwide may be affected.