Events

Recall of Device Recall Cardioplegia Delivery System

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
    26361
  • Event Risk Class
    Class 2
  • Event Number
    Z-0960-03
  • Event Initiated Date
    2003-05-09
  • Event Date Posted
    2003-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27565
  • 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
    Tubing set included in cardioplegia delivery system was 4:1 instead of the labeled 8:1 size.
  • Action
    All consignees were contacted by telephone on 05/09/2003, followed by a letter.

Device

Device Recall Cardioplegia Delivery System
  • Model / Serial
    Catalog # 027819201, Lot Number 0304300106.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, NE, OK
  • Product Description
    Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
  • Manufacturer
    Cobe Cardiovascular, Inc

Manufacturer

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