Vascular graft slider component separation reported in ADVANTA VXT
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units affected 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 recall of a high-risk medical device (vascular graft) with a confirmed structural defect (component separation and gap). No illnesses or injuries are reported in the source material, making this a risk-of-harm situation where injury has not yet been documented.
Plain-English summary
Atrium Medical Corporation is recalling the ADVANTA VXT, 6X70, 1GDS, NH, STR-TW single-ended slider vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. A notable gap has been observed between the two components.
This is a vascular graft used in surgical procedures. The reported separation and gap between these critical components represent a structural defect.
Approximately 53,308 units have been distributed worldwide: 11,236 in the United States (including Puerto Rico) and 42,072 internationally to countries including the European Union, Asia-Pacific, Middle East, Africa, and the Americas.
Healthcare providers and patients with questions should contact their physician. Any adverse events related to this device should be reported to Atrium Medical Corporation or the FDA.
The recalled product
- Product
- ADVANTA VXT, 6X70, 1GDS, NH, STR-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: 22185
- UDI-DI: 00650862221855.
Distribution
Distributed nationwide across the United States.
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