Vascular graft device recalled for swivel component separation
Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The internal component 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: FDA Class II recall for mechanical component separation in a medical implant. No illnesses or injuries are reported in the complaint data. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Product Code 22176) due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core and creating a notable gap between the two components.
Approximately 53,308 units were distributed globally, with 11,236 units distributed in the United States and Puerto Rico, and 42,072 units distributed outside the United States.
The separation of these internal components could affect the structural integrity and function of the vascular graft device. Patients and healthcare providers who have received this device should contact Atrium Medical Corporation for guidance regarding this recall.
The recalled product
- Product
- ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- 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: 22176
- UDI-DI: 00650862221763.
Distribution
Distributed nationwide across the United States.
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