Class II — Potential Health Hazard

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

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular Recalled by Baxter Healthcare Corporation Due to There is a potential for foreign matter.

Date: April 1, 2022
Company: Baxter Healthcare 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 Baxter Healthcare Corporation directly.

Affected Products

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Quantity: 300 devices

Why Was This Recalled?

There is a potential for foreign matter.

Where Was This Sold?

This product was distributed to 7 states: AL, CA, KY, NY, OR, PA, TX

Affected (7 states)Not affected

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

Related Recalls

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