Agency classClass IIOur severity:High FDA (Devices)·Z-2004-2024·Announced 2024-06-12

Vascular graft recalled for separation of slider mechanism

Atrium Medical Corporation recalls FLIXENE vascular grafts due to separation of the slider swivel rod from the core assembly. The device defect affects 53,308 units distributed worldwide.

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 medical device recall of a vascular graft. The reported separation of the slider mechanism represents a risk-of-harm defect affecting device integrity.

Plain-English summary

Atrium Medical Corporation has recalled the FLIXENE vascular graft, model 6X40, 1GDS, GW (Single-Ended Slider GDS), due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap between the two pieces. The FDA has classified this as a Class II recall.

The recalled units were distributed worldwide, including throughout the United States (including Puerto Rico) and to numerous countries. A total of 53,308 units were affected, including 11,236 units distributed in the United States and 42,072 units distributed outside the United States.

Patients who have received this device or healthcare providers managing patients with this device should contact Atrium Medical Corporation or their healthcare provider regarding the recall and appropriate next steps.

The recalled product

Product: FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Graft
Hazard: component-separation
assembly-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: 25061
UDI-DI: 00650862250619.

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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