Vascular graft recalled for slider rod component separation
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall affects 53,308 units distributed worldwide.
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 medical device with reported component separation but no reported illnesses or injuries. This recall involves a structural component separation that represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (model 8X70, 1GDS, FH, STR-SW) due to reported component separation. The recall affects 53,308 units distributed worldwide, including 11,236 in the United States and Puerto Rico, and 42,072 in other countries.
The FDA received complaints regarding separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces.
Healthcare providers who have received these devices should be aware of this recall and contact Atrium Medical Corporation with any questions or concerns.
The recalled product
- Product
- ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
- device-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: 22072
- UDI-DI: 00650862220728.
Distribution
Distributed nationwide across the United States.
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