The Recall Desk
HighFDA (Devices)·Z-1987-2024·Announced 2024-06-12

Advanta VXT vascular grafts recalled for swivel rod separation

Atrium Medical Corporation is recalling the Advanta VXT vascular graft due to reports of the swivel rod separating from the swivel core. The recall affects approximately 53,308 units distributed in the United States and 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 for a structural device defect with no reported injuries or illnesses. The product is a risk-of-harm medical device, and the separation hazard is theoretical without documented patient harm, meeting the criteria for High severity.

Plain-English summary

Atrium Medical Corporation is recalling the Advanta VXT vascular graft due to reports that the swivel rod can separate from the swivel core, leaving a gap between these components. The Advanta VXT is a medical device used in vascular grafting procedures.

The recall affects approximately 11,236 units distributed in the United States and 42,072 units distributed to over 60 countries worldwide.

Patients who received this graft and their healthcare providers should assess whether the recall affects their particular device and discuss any concerns. The FDA classified this as a Class II recall.

The recalled product

Product
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Manufacturer
Atrium Medical Corporation
Category
Medical Device — Vascular graft device
Hazard
  • device-separation
  • structural-defect

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: 22221
  • UDI-DI: 00650862222210.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category