Vascular graft recalled due to slider component separation risk
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that 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 of an implantable vascular graft with reported structural component separation. This is a risk-of-harm product where no illnesses or injuries have been reported to date. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (model 4-7X45, 1GDS, NH, TPR-SW, Single-Ended Slider GDS) following complaints of separation between the Slider GDS Swivel Rod and the Swivel Core. The separation creates a notable gap between the two components, which could affect the graft's structural integrity and function.
Approximately 53,308 units have been distributed worldwide, including 11,236 units throughout the United States and Puerto Rico. The product has been distributed to multiple countries across the globe.
The FDA has classified this as a Class II recall. Patients who have received these grafts should contact their healthcare provider to discuss whether further evaluation or monitoring is necessary. Healthcare providers and patients should be alert for any signs of device malfunction.
Questions or adverse events related to this product should be reported to Atrium Medical Corporation or the FDA.
The recalled product
- Product
- ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Hazard
- component-separation
- device-failure-risk
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: 22115
- UDI-DI: 00650862221152.
Distribution
Distributed nationwide across the United States.
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