Agency classClass IIOur severity:High FDA (Devices)·Z-1990-2024·Announced 2024-06-12

Vascular graft separation issue prompts FDA recall of Atrium Medical ADVANTA VXT units

Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.

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 FDA Class II. Per the rubric, Class II without reported hospitalizations scores at 3 (High) as a risk-of-harm medical device with no reported injuries documented.

Plain-English summary

Atrium Medical Corporation is recalling 53,308 units of its ADVANTA VXT vascular graft (Product Code: 22227). The recall addresses complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with reports of a notable gap between the two components.

The separation of these components could compromise graft function and integrity. A vascular graft that becomes separated may fail to function as intended, potentially affecting patient safety and treatment efficacy.

The affected units have been distributed worldwide, including throughout the United States and its territories, and to international customers in more than 50 countries. Within the U.S., 11,236 units were distributed; outside the U.S., 42,072 units were affected.

Healthcare facilities and physicians who have received this device should contact Atrium Medical Corporation regarding this recall. The manufacturer and FDA can provide guidance on appropriate next steps, including device replacement or other corrective actions.

The recalled product

Product: ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Grafts
Hazard: component-separation
mechanical-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: 22227
UDI-DI: 00650862222272.

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

See all →

High
Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
High
Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
High
Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
Moderate
iCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
High
Vascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12

Same hazard · component separation