Terumo Cardiovascular Systems Corporation recalls Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Recall date

January 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1232-2017

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment