Events

Recall of Device Recall Stabilizer, Heart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76346
  • Event Risk Class
    Class 2
  • Event Number
    Z-1232-2017
  • Event Initiated Date
    2015-01-05
  • Event Date Posted
    2017-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152937
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    stabilizer,heart - Product Code MWS
  • 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.
  • 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

Device

Device Recall Stabilizer, Heart
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed domestically and also to foreign consignees. But not to government agency's or Canada.
  • Product Description
    Titan" Stabilizer Attachment and Titan TM 360 Stabilizer || Attachment
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA