Vascular graft devices subject to swivel rod separation from core assembly
Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.
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 an FDA Class II recall of a vascular graft due to reported component separation in the swivel mechanism. While no injuries or hospitalizations have been reported, the structural failure of a critical component in a vascular graft poses significant risk of harm.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices (model 6X100, 1GDS, FH, STR-TW) distributed worldwide. A total of 53,308 units were distributed, including 11,236 in the United States and Puerto Rico.
The FDA has received complaints that the Slider GDS Swivel Rod can separate from the Swivel Core, with a notable gap forming between the components. This structural failure could compromise the function of the graft.
Patients who have received this device should contact their healthcare provider for guidance. Healthcare providers should review patient records to identify affected devices and contact Atrium Medical Corporation for recommendations regarding patient management.
The recalled product
- Product
- ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
- structural-failure
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: 22232
- UDI-DI: 00650862222326.
Distribution
Distributed nationwide across the United States.
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