Skip to content
Recall Observatory FDA recall evidence

Device product

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Z-1232-2017

January 05, 2015

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 76346
Status
Terminated
Classification
Class II
Quantity
1463
Official record key
device-enforcement:Z-1232-2017

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.