ADVANTA VXT vascular graft recalled for slider rod separation
Atrium Medical is recalling ADVANTA VXT vascular grafts due to complaints of separation between the slider rod and swivel core, which could affect proper device function.
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 an FDA Class II medical device with a reported structural defect (component separation) affecting a high-risk vascular graft. While the defect poses potential for patient harm, no injuries or hospitalizations have been reported.
Plain-English summary
ADVANTA VXT vascular grafts are being recalled by Atrium Medical Corporation due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, along with notable gaps between the two pieces. This separation could affect the proper function of the graft.
The recall affects 53,308 units distributed worldwide, including across the US and Puerto Rico, and to countries including Canada, Mexico, Japan, Australia, and others.
Patients who have received this device should consult with their healthcare provider regarding their individual situation. Healthcare providers and patients should report any adverse events to the FDA.
The recalled product
- Product
- ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- device-separation
- structural-defect
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: 22016
- UDI-DI: 00650862220162.
Distribution
Distributed nationwide across the United States.
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