ADVANTA VXT Vascular Graft Recalled for Slider Rod Separation
The ADVANTA VXT vascular graft is being recalled because its slider rod can separate from the swivel core, creating a gap between components. No injuries have been reported.
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 Class II medical device recall involving a mechanical defect in a vascular graft that could compromise device function. Although no illnesses or injuries have been reported, the defect affects a high-risk implantable device used in vascular surgery, warranting a High severity rating for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The ADVANTA VXT vascular graft, a single-ended slider device used in vascular surgery, is being recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Complaints indicate a notable gap can form between these two components.
Approximately 53,308 units have been affected and distributed worldwide, including 11,236 units in the United States and Puerto Rico. The device is manufactured by Atrium Medical Corporation.
No illnesses or injuries have been reported in connection with this defect. Patients or healthcare providers with questions about this recall should contact the manufacturer or their distributor for guidance.
The recalled product
- Product
- ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular grafts
- Hazard
- slider-separation
- mechanical-failure
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: 22026
- UDI-DI: 00650862220261.
Distribution
Distributed nationwide across the United States.
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