Vascular graft component separation reported in Advanta VXT devices
Atrium Medical Corporation recalls Advanta VXT vascular grafts due to separation of internal swivel components. Approximately 53,308 units worldwide are affected, with the slider GDS swivel rod potentially separating from its core.
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: This recall involves a vascular graft with a structural defect (component separation) that poses a risk of device malfunction. No injuries or adverse events have been reported in the source text, making this a high-risk medical device where injury has not yet been reported, per the rubric criterion for Score 3.
Plain-English summary
Atrium Medical Corporation is recalling Advanta VXT vascular grafts (Product Code 22220, UDI-DI: 00650862222203) due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core. Affected devices may develop a notable gap between these two components.
Approximately 53,308 units are involved in this recall, with 11,236 units distributed in the United States and Puerto Rico, and 42,072 units distributed internationally. The devices have been distributed worldwide, including to countries in North America, South America, Europe, Africa, the Middle East, and Asia-Pacific regions.
This is a Class II recall. Healthcare providers and patients should take appropriate action in consultation with the device manufacturer or their healthcare team.
The recalled product
- Product
- ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- structural-defect
- malfunction-risk
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: 22220
- UDI-DI: 00650862222203.
Distribution
Distributed nationwide across the United States.
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