Vascular Graft Slider Component May Separate from Core
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable 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 is an FDA Class II recall of a vascular graft with reported mechanical defects (component separation) but no reported illnesses or injuries. Per the rubric, recalls for risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (product code 22018), specifically the 7X50, 1GDS, NH, STR-SW single-ended slider model. The recall affects 53,308 units worldwide, including 11,236 units distributed in the United States and Puerto Rico, and 42,072 units distributed internationally.
The recall was initiated following complaints that the slider GDS swivel rod separates from the swivel core, creating a notable gap between the two components. Vascular grafts are medical devices implanted during surgical procedures to repair or replace damaged blood vessels.
Healthcare facilities and physicians who have these devices should stop using affected units and quarantine them. Patients who have received this graft implant should contact their healthcare provider immediately if they experience any complications or concerns related to the graft.
The recalled product
- Product
- ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. 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: 22018
- UDI-DI: 00650862220186.
Distribution
Distributed nationwide across the United States.
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