FDAJanuary 5, 2015device

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

terumo cardiovascular systemsterumoterumo cardiovascular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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