Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

iCast Covered Stent Recalled by Atrium Medical Corporation Due to There is an error in the Unique Device...

Date: September 9, 2024
Company: Atrium Medical Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.

Affected Products

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Quantity: 11 devices

Why Was This Recalled?

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Atrium Medical Corporation

Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report