Atrium Medical Corporation is recalling approximately 3,624,944 Advanta VXT and Flixene Vascular Grafts due to reports of a structural defect where the Slider GDS Swivel Rod can separate from the Swivel Core. This defect can lead to a visible gap between the components during medical procedures, potentially causing serious complications for patients receiving these implants. The affected units were distributed worldwide, including across the United States and Puerto Rico.
The separation of the swivel rod from the core can cause the vascular graft device to fail during or after implantation, which may lead to internal bleeding, loss of blood flow, or the need for additional emergency surgical interventions to replace the faulty device.
Manufacturer correction/return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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