Vascular Graft Component Separation Risk in ADVANTA VXT Models
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
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 a risk-of-harm product (vascular graft is a life-critical medical device) with a reported manufacturing defect (component separation). No illnesses or injuries have been reported, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling 53,308 ADVANTA VXT, 7X80, 1GDS, FH, STR-SW single-ended slider GDS vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap developing between the two components.
Affected units include 11,236 devices distributed in the United States and territories, and 42,072 units distributed internationally across multiple countries. Patients who have received these devices and their healthcare providers should consult regarding appropriate follow-up care and management options.
The recalled product
- Product
- ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- device-malfunction
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: 22076
- UDI-DI: 00650862220766.
Distribution
Distributed nationwide across the United States.
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