Vascular Graft Component Separation Risk in ADVANTA VXT Grafts
ADVANTA VXT vascular grafts are being recalled due to reported separation of the Slider GDS Swivel Rod from its core. This mechanical failure could compromise graft 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 involving a risk-of-harm implantable medical device where mechanical component separation could occur. No illnesses or injuries have been reported in the source text.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Product Code 22209) due to reported separation of the Slider GDS Swivel Rod from its Swivel Core, along with a notable gap between the two components. This mechanical failure could compromise the structural integrity of the graft during or after implantation.
The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally. These are implantable vascular grafts intended for use in vascular access or repair procedures.
Healthcare facilities and physicians who have received or implanted these grafts should cease use and contact Atrium Medical Corporation for instructions regarding affected units. Patients who have received these devices should consult with their healthcare provider about the potential risks and whether monitoring or follow-up evaluation is necessary.
The recalled product
- Product
- ADVANTA VXT, 8X40, 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: 22209
- UDI-DI: 00650862222098.
Distribution
Distributed nationwide across the United States.
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