Atrium ADVANTA VXT Vascular Graft Slider Rod Separation
ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.
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: Class II medical device recall for a mechanical component defect in an implantable vascular graft. While no injuries or illnesses are reported in the source text, the swivel rod separation represents a risk-of-harm defect in an implantable device, meeting the High severity criterion.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Product Code 22169, 6X40 model) due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the separated pieces.
The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally to countries including Canada, Western Europe, Asia, Australia, and the Middle East.
Healthcare facilities and clinicians with this device in inventory should contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
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: 22169
- UDI-DI: 00650862221695.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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