Vascular graft recalled due to slider component separation risk
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider GDS swivel rod separating from the swivel core. Approximately 53,308 units are affected worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a vascular graft with reported mechanical failure (component separation). No injuries or illnesses have been reported, making this a risk-of-harm situation rather than a confirmed-harm recall, consistent with the rubric criterion for High severity.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT, 8X50, 1GDS, NH, STR-SW Single-Ended Slider Vascular Grafts due to reports of the slider GDS swivel rod separating from the swivel core, with a notable gap forming between the two components.
This separation could affect the proper functioning of the vascular graft. The company received complaints regarding this mechanical defect.
The recall affects approximately 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units distributed internationally to countries across Europe, Asia, the Middle East, North Africa, and the Americas.
Healthcare providers who have received these grafts should contact Atrium Medical Corporation for additional information on the recall and replacement options.
The recalled product
- Product
- ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: 22019
- UDI-DI: 00650862220193.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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