Vascular Graft Device Recalled for Slider Component Separation
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider component from the swivel core. The recall affects 53,308 units 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 a Class II recall for a documented mechanical failure in a vascular graft device. Field complaints of component separation have been reported. The source does not report any associated injuries or illnesses. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) severity rating.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (product code 22014), a single-ended slider vascular graft device. The recall affects 53,308 units distributed worldwide, including 11,236 units in the US and Puerto Rico and 42,072 units distributed to other countries.
The FDA classified this as a Class II recall. The recall was initiated following complaints of separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two components.
The recalled product
- Product
- ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-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: 22014
- UDI-DI: 00650862220148.
Distribution
Distributed nationwide across the United States.
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