Events

Recall of Device Recall Cardioplegia Delivery Set

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

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
    29261
  • Event Risk Class
    Class 2
  • Event Number
    Z-1009-04
  • Event Initiated Date
    2004-05-25
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33417
  • 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
    Reservoir, Blood, Cardiopulmonary Bypass - Product Code DTN
  • Reason
    Some cardioplegia delivery sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. this would provide 2 1/2x the desired cardioplegia.
  • Action
    Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.

Device

Device Recall Cardioplegia Delivery Set
  • Model / Serial
    Catalog # 027770201, Lot # 0406800015.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
  • Product Description
    Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

Cobe Cardiovascular, Inc
  • Manufacturer Address
    Cobe Cardiovascular, Inc, 14401 W 65th Way, Arvada CO 80004-3524
  • Source
    USFDA