Vascular Graft Recall for Component Separation in ADVANTA VXT
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could compromise 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 a risk-of-harm product (vascular graft, a surgically implanted device critical to blood vessel function) where injury has not yet been reported. The FDA Class II classification and absence of reported illnesses or injuries limit the score to 3 per the rubric, despite the potential seriousness of component separation in an implanted device.
Plain-English summary
The ADVANTA VXT is a single-ended slider GDS vascular graft manufactured by Atrium Medical Corporation and distributed worldwide. Vascular grafts are surgically implanted devices used to replace or repair blood vessels.
Atrium Medical Corporation has issued a recall due to complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, as well as reports of a notable gap between these two components. This separation could compromise the structural integrity and function of the graft.
The recall affects 53,308 units worldwide, with 11,236 units distributed in the United States (including Puerto Rico) and 42,072 units distributed internationally across more than 40 countries.
Patients who have received this device should contact their healthcare provider to discuss appropriate next steps. Healthcare providers should cease use of affected product lots and consult the full recall notice for detailed instructions on returning or disposing of unused inventory.
The recalled product
- Product
- ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- 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: 22190
- UDI-DI: 00650862221909.
Distribution
Distributed nationwide across the United States.
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