The Recall Desk
HighFDA (Devices)·Z-1951-2024·Announced 2024-06-12

FDA Recalls Atrium Medical Vascular Graft for Slider Separation Defect

Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.

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 of a structural defect in a critical medical device. Although no injuries or illnesses have been reported, the separation of the slider rod from the swivel core constitutes a risk-of-harm product defect that could impair device function, meeting the rubric criterion for High severity.

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT model 5X40, 1GDS, NH, STR-SW vascular grafts due to a structural defect in the device slider mechanism.

The recall stems from complaints that the Slider GDS Swivel Rod may separate from the Swivel Core, creating a notable gap between the two components. This separation could prevent the device from functioning properly during implantation or use.

Approximately 53,308 units have been distributed worldwide, including 11,236 in the United States and Puerto Rico, and 42,072 internationally across multiple countries. Healthcare facilities, surgeons, and patients who have received this device may be affected.

Healthcare providers with this device in inventory or implanted in patients should consult Atrium Medical Corporation regarding next steps. Patients who have received this vascular graft should contact their healthcare provider if they have concerns about their device.

The recalled product

Product
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular graft
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: 22011
  • UDI-DI: 00650862220117.

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

See all →

Same hazard · component separation

See all →