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(R) Overpressure Safety Valve Recalled by Terumo Cardiovascular Systems Corporation Due to Terumo Cardiovascular Systems (Terumo CVS) has received reports...

Date: June 27, 2017
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(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

Quantity: 297,222 units

Why Was This Recalled?

Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

Where Was This Sold?

Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

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