Vascular Graft Component Separation Recall from Atrium Medical
Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation from the Swivel Core. Component separation could compromise device function.
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 implantable medical device with documented component separation defect in a vascular graft. No deaths or hospitalizations reported; however, this represents a structural risk in a high-risk implantable product where device failure could lead to serious patient harm.
Plain-English summary
Atrium Medical Corporation is recalling 53,308 units of ADVANTA VXT vascular grafts (Product Code 22061), distributed worldwide to 47+ countries and throughout the United States. The device is used in vascular surgical procedures.
The recall was initiated due to reported incidents where the Slider GDS Swivel Rod separated from the Swivel Core, with a notable gap forming between the two components. Component separation could compromise device function and patient outcomes.
The affected units include 11,236 units distributed within the United States and 42,072 units distributed internationally. Healthcare providers and patients who have received this device should contact Atrium Medical Corporation or consult with their healthcare provider regarding appropriate follow-up actions.
The recalled product
- Product
- ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular grafts
- 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: 22061
- UDI-DI: 00650862220612.
Distribution
Distributed nationwide across the United States.
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