Class II — Potential Health Hazard

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

Base for Terumo Advanced Perfusion System 1 Recalled by Terumo Cardiovascular Systems Corporation Due to Terumo CVS is implementing field correction activities to...

Date: May 1, 2015
Company: Terumo Cardiovascular Systems Corporation
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 Terumo Cardiovascular Systems Corporation directly.

Affected Products

Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Quantity: 1713 units total

Why Was This Recalled?

Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.

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