Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

FDA device recall Z-1232-2017 · posted 2017-02-22 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

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.

Action taken

A recall notification is being forwarded to all users and consignees who have received product. The notification of this voluntary recall will be sent to the following consignee in each facility:+ Director of Operating Room Services Proposed Level of Effectiveness Checks: Terumo CVS will verify that 100% of all letters are delivered to affected consignees

Root cause

Other

Status

Terminated

Product code

MWS

Quantity affected

1463

Distribution

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

Date initiated

2015-01-05

Date posted

2017-02-22

Date terminated

2017-02-23

Location

Elkton, MD