Agency classClass IIOur severity:High FDA (Devices)·Z-1970-2024·Announced 2024-06-12

Vascular graft recalled for slider rod component separation

Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from its Swivel Core. The recall 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: FDA Class II medical device with reported component separation but no reported illnesses or injuries. This recall involves a structural component separation that represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (model 8X70, 1GDS, FH, STR-SW) due to reported component separation. The recall affects 53,308 units distributed worldwide, including 11,236 in the United States and Puerto Rico, and 42,072 in other countries.

The FDA received complaints regarding separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces.

Healthcare providers who have received these devices should be aware of this recall and contact Atrium Medical Corporation with any questions or concerns.

The recalled product

Product: ADVANTA VXT, 8X70, 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: 22072
UDI-DI: 00650862220728.

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