Events

Recall of Device Recall Sarns Flexible Weighted 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
    58125
  • Event Risk Class
    Class 2
  • Event Number
    Z-2006-2011
  • Event Initiated Date
    2011-02-25
  • Event Date Posted
    2011-04-15
  • 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=98691
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    The firm has received two reports of the terumo weighted flexible sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. the firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. however this is not stated in the ifu. the firm is conducting.
  • Action
    SEE UPDATE BELOW IN ALL CAPS. The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only). If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM. ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM.

Device

Device Recall Sarns Flexible Weighted Sucker
  • Model / Serial
    Lot numbers: MK23, MN29, and NC07.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA.
  • Product Description
    Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA . || The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field.
  • 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