ADVANTA VXT Vascular Graft Recalled for Component Separation
ADVANTA VXT vascular grafts are recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a 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 device recall involving reported component separation of a vascular graft. The separation creates a structural defect that poses a risk of device malfunction. No illnesses or injuries are reported in the source, which limits the score per the rubric to a maximum of 3 (High: risk-of-harm products where injury has not yet been reported).
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (7X70, 1GDS, NH, STR-TW with single-ended slider GDS design) due to reported component separation issues. The Slider GDS Swivel Rod may separate from the Swivel Core, creating a notable gap between the two pieces.
Affected units were distributed worldwide. In the US, 11,236 units were distributed nationwide including Puerto Rico. An additional 42,072 units were distributed internationally.
Complaints have been received regarding the separation of the Slider GDS Swivel Rod from the Swivel Core. Patients and healthcare providers who have received this device should contact Atrium Medical Corporation for guidance. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- structural-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: 22186
- UDI-DI: 00650862221862.
Distribution
Distributed nationwide across the United States.
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