Vascular graft separation issue prompts FDA recall of Atrium Medical ADVANTA VXT units
Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.
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 FDA Class II. Per the rubric, Class II without reported hospitalizations scores at 3 (High) as a risk-of-harm medical device with no reported injuries documented.
Plain-English summary
Atrium Medical Corporation is recalling 53,308 units of its ADVANTA VXT vascular graft (Product Code: 22227). The recall addresses complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with reports of a notable gap between the two components.
The separation of these components could compromise graft function and integrity. A vascular graft that becomes separated may fail to function as intended, potentially affecting patient safety and treatment efficacy.
The affected units have been distributed worldwide, including throughout the United States and its territories, and to international customers in more than 50 countries. Within the U.S., 11,236 units were distributed; outside the U.S., 42,072 units were affected.
Healthcare facilities and physicians who have received this device should contact Atrium Medical Corporation regarding this recall. The manufacturer and FDA can provide guidance on appropriate next steps, including device replacement or other corrective actions.
The recalled product
- Product
- ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Grafts
- 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: 22227
- UDI-DI: 00650862222272.
Distribution
Distributed nationwide across the United States.
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