ADVANTA VXT Vascular Grafts Recalled for Slider Rod Separation
Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the slider rod from the swivel core, with a gap observed between the components.
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 with reported structural component separation in a vascular graft, posing risk of device malfunction. No injuries or hospitalizations are reported in this recall notice.
Plain-English summary
Atrium Medical Corporation is recalling 53,308 units of ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core. The affected devices have been observed with a notable gap between the separated components.
The recall includes 11,236 units distributed in the United States (including Puerto Rico) and 42,072 units distributed internationally to numerous countries, including Canada, Japan, Australia, and countries in Europe and Asia. The affected product code is 22075 with UDI-DI 00650862220759. This is an FDA Class II recall.
The recalled product
- Product
- ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. 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: 22075
- UDI-DI: 00650862220759.
Distribution
Distributed nationwide across the United States.
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