ADVANTA VXT Vascular Graft Slider Component Separation Recall
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from its core component. This mechanical failure could compromise device functionality.
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: FDA Class II recall with no reported illnesses or injuries to date. However, this involves a risk-of-harm product (implanted vascular graft) where documented structural component separation could compromise device functionality and patient safety.
Plain-English summary
ADVANTA VXT vascular grafts manufactured by Atrium Medical Corporation are being recalled. The FDA reports that customers have complained of separation between the slider GDS swivel rod and the swivel core, with a notable gap appearing between the two pieces.
The slider mechanism is a critical structural component of the vascular graft device. If the rod separates from the core, it may compromise the graft's integrity and functionality, which could affect patient safety during or after vascular procedures.
The recall affects 53,308 total units distributed worldwide. In the United States and Puerto Rico, 11,236 units were distributed. The remainder were distributed internationally to over 50 countries. Atrium Medical Corporation is the recalling firm.
Patients and healthcare providers who have these devices should contact Atrium Medical Corporation for guidance. Healthcare facilities should evaluate whether affected devices require replacement or additional assessment before clinical use.
The recalled product
- Product
- ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Grafts
- Hazard
- component-separation
- device-malfunction
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: 22187
- UDI-DI: 00650862221879.
Distribution
Distributed nationwide across the United States.
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