Vascular Graft Swivel Rod Separation Recalled Due to Component Failure
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect 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: FDA Class II recall of a high-risk vascular graft with reported component separation. No injuries or hospitalizations are documented in the source text. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Product Code 22214) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the two pieces. This is a Class II recall.
Vascular grafts are medical devices used to restore blood flow in patients. Component separation could potentially compromise the device's structural integrity and its ability to function properly.
The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units in other countries. Distribution was made to numerous nations across North America, South America, Europe, Asia, Africa, and the Middle East.
Patients and healthcare providers who have received affected devices should contact Atrium Medical Corporation for instructions on how to proceed. Patients should not attempt to remove or replace implanted devices without guidance from their healthcare provider.
The recalled product
- Product
- ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-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: 22214
- UDI-DI: 00650862222142.
Distribution
Distributed nationwide across the United States.
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