Class II — Potential Health Hazard

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

Extra corporeal circuit with bio-active surface. Recalled by Medtronic Perfusion Systems Due to Affected products failed a sterilization test.

Date: August 8, 2018
Company: Medtronic Perfusion Systems
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 Medtronic Perfusion Systems directly.

Affected Products

Extra corporeal circuit with bio-active surface.

Quantity: 10 units

Why Was This Recalled?

Affected products failed a sterilization test.

Where Was This Sold?

This product was distributed to 2 states: CA, MI

Affected (2 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