Events

Recall of Sarns Rigid Intracardiac Sucker

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
    59912
  • Event Risk Class
    Class 2
  • Event Number
    Z-0053-2012
  • Event Initiated Date
    2011-09-13
  • Event Date Posted
    2011-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103985
  • 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
    Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
  • Reason
    Terumo cardiovascular systems (terumo cvs) recently discovered three instances of metal fragments inside the stainless steel tube of the sarns" adult rigid intracardiac sucker.
  • Action
    On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.

Device

Sarns Rigid Intracardiac Sucker
  • Model / Serial
    Catalog number 4300 and CV-4300
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.
  • Product Description
    Sarns Rigid Intracardiac Sucker. || The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA