Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2017 - (Recall #: Z-1232-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Product Classification:

Class II

Date Initiated: January 5, 2015

Date Posted: March 1, 2017

Recall Number: Z-1232-2017

Event ID: 76346

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.

Status: Terminated

Product Quantity: 1463

Code Information:

Catalog Number: 401-231, Product Description: Titan" Stabilizer Attachment , Lot Number: 052R Catalog Number 401-231u , Product Description TitanTM 360 Stabilizer Attachment , Lot Number: 020R, 024R, 026R, 029R, 030R,034R,035R,037R, 040 , 048R

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated