The Recall Desk
HighFDA (Devices)·Z-1988-2024·Announced 2024-06-12

Vascular graft component separation risk: ADVANTA VXT slider rod defect

Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.

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: FDA Class II device with documented complaints of component separation affecting a critical component, but without reported patient injuries or illnesses. This meets the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT, 8X70, 1GDS, FH, STR-TW single-ended slider GDS vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap reported between the two pieces.

This component separation could affect the device's functionality and performance. Because vascular grafts are surgical implants used in vascular access procedures, any defect affecting component integrity poses a potential risk to patient outcomes.

Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally to over 90 countries and territories.

Healthcare providers who received these devices should contact Atrium Medical Corporation for guidance and instructions regarding the recall.

The recalled product

Product
ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. 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: 22222
  • UDI-DI: 00650862222227.

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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