Agency classClass IIOur severity:High FDA (Devices)·Z-2012-2024·Announced 2024-06-12

Vascular Graft Swivel Component Separation Recall Affects Thousands Nationwide

FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 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 with reported component separation in an implanted vascular graft. No illnesses or injuries reported, but the mechanical defect poses a risk given the critical nature of vascular grafts.

Plain-English summary

Atrium Medical Corporation is recalling FLIXENE vascular grafts (model 4-6X35, 2GDS, GWT-GW). These are double-ended slider grafts with swivel technology used in vascular applications. The company received complaints that the swivel rod separates from the swivel core, with patients and providers reporting a notable gap between the two pieces.

The recall affects 53,308 units worldwide. In the United States, 11,236 units were distributed (including Puerto Rico). An additional 42,072 units were distributed internationally across 60 countries.

The FDA classified this as a Class II medical device recall (Z-2012-2024).

The recalled product

Product: FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular grafts
Hazard: component-separation
device-malfunction

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: 25128
UDI-DI: 00650862251289.

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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