Vascular Graft Recalled Due to Slider Component Separation Risk
Atrium Medical's ADVANTA VXT vascular grafts are recalled due to reported separation of the slider component from the swivel core. Over 53,000 units worldwide may be affected.
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 involving mechanical separation of a vascular graft component. No injuries or illnesses are reported in the source text, and the hazard is a risk-of-harm condition where the defect has not yet caused reported injury, meeting the criteria for a High severity rating.
Plain-English summary
Atrium Medical Corporation is recalling approximately 53,308 units of the ADVANTA VXT single-ended slider vascular graft (Product Code 22028; UDI-DI 00650862220285). The recall is being issued by the FDA as a Class II recall.
The company has received complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap reported between the two pieces. This mechanical defect could potentially affect the proper function of the graft.
The affected units have been distributed worldwide, including throughout the United States (including Puerto Rico) and internationally. Healthcare providers and patients who have received this product should contact their healthcare provider or medical facility if they have any concerns regarding their implanted graft.
The recalled product
- Product
- ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. 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: 22028
- UDI-DI: 00650862220285.
Distribution
Distributed nationwide across the United States.
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