Vascular graft separation defect recalled by Atrium Medical
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of internal components. The defect affects over 53,000 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 recall with confirmed mechanical defect but no reported injuries or hospitalizations. The hazard involves a life-critical vascular graft where component separation creates risk of device failure and potential harm, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The separation creates a notable gap between the two components, potentially compromising device function.
The recalled products include 53,308 units distributed worldwide, with 11,236 units in the United States (including Puerto Rico) and 42,072 units distributed internationally. The products are identified by Product Code 22212 and UDI-DI 00650862222128.
Patients and healthcare providers who have this device should contact Atrium Medical Corporation. No injuries or illnesses have been reported at this time.
The recalled product
- Product
- ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
- mechanical-defect
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: 22212
- UDI-DI: 00650862222128.
Distribution
Distributed nationwide across the United States.
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