The Recall Desk
HighFDA (Devices)·Z-1952-2024·Announced 2024-06-12

Vascular graft recall: Advanta VXT swivel rod separation

Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.

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 an FDA Class II recall with no reported illnesses, injuries, or deaths in the source text. The hazard involves structural failure of a critical component in a surgical implant, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Atrium Medical Corporation is recalling Advanta VXT vascular grafts (model 6X40, 1GDS, NH, STR-SW) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between these components. Approximately 53,308 units have been distributed worldwide, including 11,236 in the United States and Puerto Rico, and 42,072 internationally.

The separation of the swivel rod from the swivel core could compromise the intended function of the vascular graft device. This recall was initiated based on complaints received regarding this separation and the resulting gap between the two pieces.

Patients who have received this device and healthcare providers should contact Atrium Medical Corporation for instructions on the appropriate course of action.

The recalled product

Product
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular Graft / Surgical Implant
Hazard

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: 22012
  • UDI-DI: 00650862220124.

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 →

Related recalls

Same manufacturer · Atrium Medical Corporation

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Same hazard · component separation

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