Vascular graft recall due to slider mechanism separation defect
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and 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: This is an FDA Class II recall of a high-risk medical device (vascular graft) with a structural defect that could affect device function and patient safety. No illnesses or injuries have been reported in the source, placing it in the High category per the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft (Product Code 22124), a medical device used in vascular procedures. The device is a single-ended slider GDS vascular graft with dimensions of 4-6X45mm.
The recall was initiated due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, creating a notable gap between the two components. This mechanical defect could compromise the device's structural integrity and functionality during or after implantation.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico. Distribution extends to over 50 countries across multiple continents, including Canada, the United Kingdom, Australia, Japan, and numerous other nations.
Healthcare providers who have received this product should discontinue use of affected units immediately. Patients who have had this graft implanted should contact their healthcare provider for evaluation and guidance. Additional information is available from Atrium Medical Corporation and the FDA.
The recalled product
- Product
- ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- device-separation
- implant-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: 22124
- UDI-DI: 00650862221244.
Distribution
Distributed nationwide across the United States.
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