Class II — Potential Health Hazard

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

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog Recalled by Terumo Cardiovascular Systems Corporation Due to intermittent failure causes a blender initialization fault upon...

Date: June 8, 2021
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

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Quantity: 1 unit OUS

Why Was This Recalled?

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Where Was This Sold?

International distribution in the country of Panama.

About Terumo Cardiovascular Systems Corporation

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

Related Recalls

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