Agency classClass IIOur severity:High FDA (Devices)·Z-1978-2024·Announced 2024-06-12

ADVANTA VXT Vascular Graft Recalled for Component Separation

ADVANTA VXT vascular grafts are recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.

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: This is an FDA Class II device recall involving reported component separation of a vascular graft. The separation creates a structural defect that poses a risk of device malfunction. No illnesses or injuries are reported in the source, which limits the score per the rubric to a maximum of 3 (High: risk-of-harm products where injury has not yet been reported).

Plain-English summary

Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts (7X70, 1GDS, NH, STR-TW with single-ended slider GDS design) due to reported component separation issues. The Slider GDS Swivel Rod may separate from the Swivel Core, creating a notable gap between the two pieces.

Affected units were distributed worldwide. In the US, 11,236 units were distributed nationwide including Puerto Rico. An additional 42,072 units were distributed internationally.

Complaints have been received regarding the separation of the Slider GDS Swivel Rod from the Swivel Core. Patients and healthcare providers who have received this device should contact Atrium Medical Corporation for guidance. No illnesses or injuries have been reported at this time.

The recalled product

Product: ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Graft
Hazard: component-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: 22186
UDI-DI: 00650862221862.

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 →

Same manufacturer · Atrium Medical Corporation

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Same hazard · component separation