Atrium ADVANTA VXT Vascular Graft may lack required radial support ring
Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a vascular graft with a manufacturing defect where some units may lack a critical structural component (radial support ring). This affects a high-risk surgical device; scored as High (3) per FDA Class II classification and risk-of-harm product criteria.
Plain-English summary
Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft (Part No. 22059, UDI 00650862220599) due to a manufacturing defect. Some product packages may contain a mismatched graft that does not contain the radial support ring (helix) identified in the product labeling.
The affected product is intended for use in arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access. The missing radial support ring is a critical structural component, and its absence could affect the graft's structural integrity and performance during vascular surgery.
The recalled products are identified by Lot 458755, with serial numbers ranging from 458755001 through 458755030. The product has been distributed worldwide, including the United States (Florida), South Korea, and Poland.
Patients and healthcare providers who have received this product should verify their unit's serial number against the recalled lot and serial numbers. Any facilities or patients with affected units should contact Atrium Medical Corporation or their healthcare provider immediately.
The recalled product
- Product
- Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Affected units
- 28
Distribution
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