Z-1232-2017Class II

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

Name: Z-1232-2017 Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-01-05
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-01-05 / Terminated

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment on 2015-01-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1232-2017
Classification: Class II
Status: Terminated
Initiated: 2015-01-05
Posted: 2017-02-22
Terminated: 2017-02-23
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Product code: MWS Stabilizer, Heart
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.
FDA root cause: Other
Action: 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
Quantity in commerce: 1463
Distribution: The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1232-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)