Agency classClass IIOur severity:High FDA (Devices)·Z-1968-2024·Announced 2024-06-12

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
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: 22070
UDI-DI: 00650862220704.

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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.

See all 68 products in this recall →

Same manufacturer · Atrium Medical Corporation

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