Class II — Potential Health Hazard

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

Medtronic DLP Aortic Root Cannula with Flow-Guard Recalled by Medtronic Perfusion Systems Due to There is the potential for a potential sterility...

Date: October 3, 2024
Company: Medtronic Perfusion Systems
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 Medtronic Perfusion Systems directly.

Affected Products

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Quantity: 420 units

Why Was This Recalled?

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Where Was This Sold?

This product was distributed to 7 states: IL, MI, NJ, NY, OH, TN, WI

Affected (7 states)Not affected

About Medtronic Perfusion Systems

Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.

Related Recalls

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