Vascular graft separation reported in ADVANTA VXT medical devices
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units have been affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a high-risk vascular graft with verified separation of critical functional components reported through customer complaints. Although no illnesses or injuries are reported in the source, the product carries risk of harm, and the defect is documented rather than theoretical.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Single-Ended Slider GDS model) due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core, with some units showing a notable gap between these components.
The recall involves approximately 53,308 units distributed worldwide: 11,236 in the United States and its territories, and 42,072 internationally across more than 50 countries.
Patients and healthcare providers who may have this product should contact Atrium Medical Corporation or their healthcare provider for further guidance regarding the recall.
The recalled product
- Product
- ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
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: 22213
- UDI-DI: 00650862222135.
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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