FDA Recalls ADVANTA VXT Vascular Grafts Due to Component Separation
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are 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 FDA Class II recall involves a mechanical component separation defect in an implanted medical device with no reported injuries or illnesses to date. The hazard meets the rubric criterion for high-severity recalls: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts, specifically the 5-8X80, 1GDS, FH, TPR-TW Single-Ended Slider GDS model. A total of 53,308 units have been recalled, including 11,236 distributed in the United States and Puerto Rico, with the remainder distributed internationally across multiple countries.
The recall is due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core, with a notable gap forming between the two pieces. This separation could compromise the graft's structural integrity and function during use.
Healthcare facilities and providers should immediately stop using recalled units. Patients who have received these grafts should consult with their healthcare provider regarding any necessary follow-up monitoring or evaluation. For product identification, the FDA product code is 22267, and the UDI-DI is 00650862222678.
The recalled product
- Product
- ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- mechanical-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: 22267
- UDI-DI: 00650862222678.
Distribution
Distributed nationwide across the United States.
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