Agency classClass IIOur severity:High FDA (Devices)·Z-1995-2024·Announced 2024-06-12

Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT

Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.

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 recall of a medical device with documented mechanical separation of a critical structural component. While no injuries or illnesses are reported in the source, the failure of a vascular graft component poses a potential risk of device failure during clinical use.

Plain-English summary

Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft following complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces. The device is used in vascular procedures, and this component separation could affect device performance.

Approximately 53,308 units were distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units in international markets spanning multiple countries. The product code is 22116 (UDI-DI: 00650862221169).

The FDA has classified this as a Class II recall. Patients and healthcare providers who may be affected by this component separation should seek information from Atrium Medical Corporation or their healthcare provider.

The recalled product

Product: ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Graft
Hazard: component-separation
device-failure

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: 22116
UDI-DI: 00650862221169.

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