The Recall Desk
HighFDA (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.

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 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
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.