Vascular graft recalled for reported swivel rod separation from core
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.
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: FDA Class II medical device recall with reported structural separation of components; no illnesses or injuries reported, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT 8X80 single-ended slider vascular grafts due to reported component separation. The recall affects 53,308 units worldwide, including 11,236 units distributed in the United States and Puerto Rico, with additional distribution to multiple countries.
Complaints were received regarding separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap developing between the components. This mechanical issue prompted the recall.
Healthcare providers and patients who have received this product should contact Atrium Medical Corporation or their healthcare provider for guidance on whether replacement or other action is needed.
The recalled product
- Product
- ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-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: 22192
- UDI-DI: 00650862221923.
Distribution
Distributed nationwide across the United States.
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