Agency classClass IIOur severity:High FDA (Devices)·Z-1969-2024·Announced 2024-06-12

Vascular graft component separation: Atrium Medical ADVANTA VXT recall

Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.

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 with a structural defect (component separation) that could pose a risk of harm in a critical implanted device. No injuries or illnesses are reported in the source material, but the actual reported complaints of separation in a vascular graft represent a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Atrium Medical Corporation is recalling the ADVANTA VXT 7X70 vascular graft (Product Code 22071) due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap forming between these two components. This separation could compromise the structural integrity of the device.

Approximately 53,308 units have been affected worldwide, including 11,236 units distributed in the United States and 42,072 units distributed internationally. The device is used in vascular surgery and has been distributed nationwide in the US, including Puerto Rico, and across more than 50 countries.

Healthcare providers who have received or implanted these devices should contact Atrium Medical Corporation for instructions on how to identify affected devices and determine appropriate next steps. Patients with implanted devices should consult their healthcare provider if they have concerns.

The recalled product

Product: ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Vascular Graft
Hazard: component-separation
structural-failure
mechanical-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: 22071
UDI-DI: 00650862220711.

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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