ADVANTA VXT vascular graft recalled for swivel rod separation
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.
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 an FDA Class II recall for a risk-of-harm medical device with reported component separation but no documented illnesses or injuries. The defect presents potential functional risk without confirmed patient harm.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (model 6X50, 1GDS, NH, STR-TW, Single-Ended Slider GDS) following complaints of the Slider GDS Swivel Rod separating from the Swivel Core, with a notable gap reported between the two pieces.
The separation and gap between these components could affect proper graft function. Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico.
Patients and healthcare providers who have received this product should consult with their healthcare provider or contact Atrium Medical Corporation for guidance. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ADVANTA VXT, 6X50, 1GDS, NH, 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: 22175
- UDI-DI: 00650862221756.
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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