Class II — Potential Health Hazard

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

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment Recalled by Terumo Cardiovascular Systems Corporation Due to Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling...

Date: January 5, 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

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Quantity: 1463

Why Was This Recalled?

Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience purposes and is not required for device operation, there is a potential for broken Suction Tubing Clip fragments to fall into the surgical site.

Where Was This Sold?

The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.

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