ADVANTA VXT Vascular Graft Recalled for Swivel Rod Separation Risk
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts after reports of separation between the Slider GDS Swivel Rod and Swivel Core. This structural defect could affect device performance.
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 medical device recall with reported structural defects in a high-risk vascular graft. No illnesses or injuries reported in the source. Classified as High due to the structural defect in a high-risk product where device failure is possible, but without reported harm.
Plain-English summary
The ADVANTA VXT vascular graft, designated as 6X80, 1GDS, FH, STR-TW, manufactured by Atrium Medical Corporation, is being recalled. This single-ended slider vascular graft is used in vascular medical procedures. The recall affects approximately 53,308 units, with 11,236 in the United States and 42,072 distributed internationally across numerous countries.
Complaints have been received of separation of the Slider GDS Swivel Rod from the Swivel Core, including reports of a notable gap between these two components. This separation could affect the device's structural integrity and function during use.
Healthcare facilities and providers in possession of affected units should refer to FDA recall notice Z-1989-2024 for complete information and instructions from Atrium Medical Corporation regarding replacement or return of affected devices.
The recalled product
- Product
- ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Grafts
- Hazard
- device-separation
- structural-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: 22225
- UDI-DI: 00650862222258.
Distribution
Distributed nationwide across the United States.
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