Agency classClass IIOur severity:High FDA (Devices)·Z-1955-2024·Announced 2024-06-12

Vascular Graft Component Separation Recall: ADVANTA VXT Slider

Atrium Medical recalls ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. The defect affects 53,308 units distributed worldwide.

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 FDA Class II recall involves mechanical separation of a critical component in a high-risk vascular graft. The severity rubric classifies Class II recalls without reported hospitalization or significant injury as High (score 3).

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT, 6X50, 1GDS, NH, STR-SW single-ended slider vascular grafts due to a mechanical defect. Product Code 22017; UDI-DI: 00650862220179.

The recalled grafts have been reported to separate at the Slider GDS Swivel Rod connection point from the Swivel Core, with a notable gap appearing between the two components. This separation could compromise the integrity and functionality of the vascular graft.

The recall covers 53,308 units distributed worldwide: 11,236 units in the United States (including Puerto Rico) and 42,072 units across approximately 50 countries.

Healthcare providers and facilities should verify their inventory against the product code and contact Atrium Medical Corporation for information about replacement or corrective actions.

The recalled product

Product: ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. 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: 22017
UDI-DI: 00650862220179.

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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Same hazard · component separation