High FDA (Devices)·Z-1993-2024·Announced 2024-06-12

Vascular graft component separation reported in ADVANTA VXT devices

Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. 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 medical device with a reported mechanical defect affecting a critical structural component. Although no injuries or deaths have been reported, vascular grafts are risk-of-harm products where component separation could compromise device function and patient safety.

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT 4-6X45 vascular grafts (Product Code 22114) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two components.

The separation of these critical components could affect the graft's structural integrity and ability to function as intended during implantation or use.

Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally across dozens of countries.

Patients and healthcare providers with these devices should contact Atrium Medical Corporation for guidance regarding the recalled product.

The recalled product

Product: ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Graft
Hazard: component-separation
mechanical-defect

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: 22114
UDI-DI: 00650862221145.

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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Vascular graft separation reported in ADVANTA VXT medical devices
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Same hazard · component separation