ADVANTA VXT Vascular Graft Slider Rod Separation Recall
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core, with a gap between components. Approximately 53,308 units are affected globally.
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 medical device recall involving a documented structural defect (separation of slider rod from swivel core) in an implantable vascular graft. No injuries or hospitalizations are reported in the source material. The mechanical defect presents a potential risk of device malfunction, warranting High severity given the critical nature of vascular grafts and the documented failure mode.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (5X40, 1GDS, FH, STR-SW model), which are single-ended slider GDS type vascular grafts. The product code is 22058, with UDI-DI 00650862220582.
The recall was initiated following complaints of separation of the slider rod from the swivel core, with a notable gap reported between the two components.
The recall affects 53,308 units total: 11,236 units distributed in the United States and Puerto Rico, and 42,072 units distributed internationally to numerous countries worldwide.
The FDA has classified this as a Class II recall. Further information regarding affected devices is available from Atrium Medical Corporation.
The recalled product
- Product
- ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- mechanical-defect
- separation-defect
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: 22058
- UDI-DI: 00650862220582.
Distribution
Distributed nationwide across the United States.
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