Vascular graft recall: Advanta VXT swivel rod separation
Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. 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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths in the source text. The hazard involves structural failure of a critical component in a surgical implant, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling Advanta VXT vascular grafts (model 6X40, 1GDS, NH, STR-SW) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between these components. Approximately 53,308 units have been distributed worldwide, including 11,236 in the United States and Puerto Rico, and 42,072 internationally.
The separation of the swivel rod from the swivel core could compromise the intended function of the vascular graft device. This recall was initiated based on complaints received regarding this separation and the resulting gap between the two pieces.
Patients who have received this device and healthcare providers should contact Atrium Medical Corporation for instructions on the appropriate course of action.
The recalled product
- Product
- ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Hazard
- component-separation
- device-malfunction
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: 22012
- UDI-DI: 00650862220124.
Distribution
Distributed nationwide across the United States.
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