Class II — Potential Health Hazard

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

Sorin Group Aortic Arch Cannula Recalled by Sorin Group USA, Inc. Due to Identification of excess plastic on the tip of...

Date: June 9, 2017
Company: Sorin Group USA, Inc.
Status: Terminated
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 Sorin Group USA, Inc. directly.

Affected Products

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Quantity: 105,770 units

Why Was This Recalled?

Identification of excess plastic on the tip of the cannula.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sorin Group USA, Inc.

Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.

Related Recalls

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