The Recall Desk
HighFDA (Devices)·Z-1973-2024·Announced 2024-06-12

Atrium ADVANTA VXT Vascular Graft Slider Rod Separation

ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.

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: Class II medical device recall for a mechanical component defect in an implantable vascular graft. While no injuries or illnesses are reported in the source text, the swivel rod separation represents a risk-of-harm defect in an implantable device, meeting the High severity criterion.

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (Product Code 22169, 6X40 model) due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the separated pieces.

The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally to countries including Canada, Western Europe, Asia, Australia, and the Middle East.

Healthcare facilities and clinicians with this device in inventory should contact Atrium Medical Corporation for further instructions.

The recalled product

Product
ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular Graft
Hazard
  • component-separation

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: 22169
  • UDI-DI: 00650862221695.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category