—#152937

Product

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

FDA product code: MWS — Stabilizer, Heart
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

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

Timeline

Recall initiated: 2015-01-05
Posted by FDA: 2017-02-22
Terminated: 2017-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.