ADVANTA VXT Vascular Graft Slider Component Separation Recall
Atrium Medical Corporation is recalling its ADVANTA VXT vascular graft due to reports that the Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between components.
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 recall is classified as High severity because the product presents a risk of harm (component failure in a critical-use vascular graft) where no injuries or illnesses have been reported in the source documentation. The FDA Class II classification indicates potential serious health consequences if the device fails.
Plain-English summary
Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft (model 7X50, 1GDS, FH, STR-SW) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This is an FDA Class II recall.
The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units distributed internationally to multiple countries. The product is identified by Product Code 22063 and UDI-DI 00650862220636.
Healthcare providers should contact Atrium Medical Corporation for information regarding the recalled device.
The recalled product
- Product
- ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
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: 22063
- UDI-DI: 00650862220636.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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