Vascular graft component separation reported in ADVANTA VXT devices
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.
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 medical device with a reported mechanical defect affecting a critical structural component. Although no injuries or deaths have been reported, vascular grafts are risk-of-harm products where component separation could compromise device function and patient safety.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT 4-6X45 vascular grafts (Product Code 22114) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two components.
The separation of these critical components could affect the graft's structural integrity and ability to function as intended during implantation or use.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally across dozens of countries.
Patients and healthcare providers with these devices should contact Atrium Medical Corporation for guidance regarding the recalled product.
The recalled product
- Product
- ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- mechanical-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: 22114
- UDI-DI: 00650862221145.
Distribution
Distributed nationwide across the United States.
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