ADVANTA VXT vascular graft slider component separation recall
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed 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: This is a risk-of-harm medical device (vascular graft) where component separation could result in serious patient harm. No injuries are reported in the source material. The FDA classified this as a Class II recall, and the mechanical defect poses significant risk to patient safety.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (model 8X50, 1GDS, FH, STR-SW) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces.
The separation occurs in the single-ended slider GDS component of the vascular graft, which is used in vascular procedures. This mechanical defect could compromise the graft's functionality and structural integrity during or after implantation.
A total of 53,308 units have been distributed worldwide, including 11,236 units in the United States (including Puerto Rico) and 42,072 units internationally across numerous countries including Canada, the United Kingdom, Australia, Japan, Korea, and others.
The recalled product
- Product
- ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
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: 22064
- UDI-DI: 00650862220643.
Distribution
Distributed nationwide across the United States.
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