Vascular graft slider component may separate from core
Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been 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 a Class II recall of an implanted vascular graft with mechanical failure (component separation). The source reports no injuries or deaths. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Atrium Medical Corporation has recalled the ADVANTA VXT vascular graft (model 6X70, 1GDS, FH, STR-SW) due to reported separation of the slider mechanism from the swivel core, creating a gap between the two components.
The recalled product was distributed worldwide. In the United States and territories, 11,236 units were distributed. An additional 42,072 units were distributed internationally across numerous countries.
Patients with this implant should consult their healthcare provider about the potential impact of this recall and any necessary follow-up.
The recalled product
- Product
- ADVANTA VXT, 6X70, 1GDS, FH, STR-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: 22070
- UDI-DI: 00650862220704.
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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