Class II — Potential Health Hazard

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

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides Recalled by Terumo Cardiovascular Systems Corporation Due to Inaccurrate flow readings. Depending on the degree of...

Date: January 19, 2018
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

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

Quantity: 7

Why Was This Recalled?

Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

Where Was This Sold?

This product was distributed to 3 states: IL, KY, MI

Affected (3 states)Not affected

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