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 ADVANTA VXT vascular grafts worldwide due to reports of separation between the swivel rod and swivel core. The component failure could affect graft function.
ADVANTA VXT vascular grafts are being recalled due to reported separation of the Slider GDS Swivel Rod from its core. This mechanical failure could compromise graft function.
ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.
Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.
Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core, with a gap between components. Approximately 53,308 units are affected globally.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft function.
Atrium Medical Corporation recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.
Atrium Medical recalls FLIXENE vascular grafts due to complaints of slider rod separation from the swivel core, which could affect device function.
Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could compromise device function.
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider component from the swivel core. The recall affects 53,308 units worldwide.
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are affected.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect device function.