Events

Recall of Device Recall Clear Cardioplegia Delivery Sets

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

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
    58185
  • Event Risk Class
    Class 2
  • Event Number
    Z-0158-2015
  • Event Initiated Date
    2011-03-01
  • Event Date Posted
    2014-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98879
  • 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
    Heat-exchanger, cardiopulmonary bypass - Product Code DTR
  • Reason
    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line.
  • Action
    Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.

Device

Device Recall Clear Cardioplegia Delivery Sets
  • Model / Serial
    Lot Numbers: MN08, MNI5, MM11, MM18, MM25.  Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
  • Product Description
    Terumo Cardioplegia Delivery Set- || Item Number: 16130 || Product Usage: || The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA