Vascular Graft Swivel Rod Separation Reported in ADVANTA VXT Devices
Atrium Medical recalls ADVANTA VXT vascular grafts due to reported separation of the slider swivel rod from its core, creating a gap between components. No injuries reported.
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 medical device recall involving a structural component separation in a vascular graft that could compromise device function. No injuries or hospitalizations have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting a High severity score.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, creating a notable gap between the two pieces.
The affected devices have been distributed worldwide, including throughout the United States and its territories, as well as in numerous other countries. A total of 53,308 units were distributed globally (11,236 in the US; 42,072 outside the US).
Healthcare providers and patients with these devices should consult with their physician regarding appropriate management options.
The recalled product
- Product
- ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
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: 22125
- UDI-DI: 00650862221251.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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