Events

Recall of Device Recall CS300 IntraAortic Balloon Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope 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
    55649
  • Event Risk Class
    Class 2
  • Event Number
    Z-1812-2010
  • Event Initiated Date
    2010-05-10
  • Event Date Posted
    2010-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91456
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Reason
    Certain maquet/datascope intra-aortic balloon pumps (iabp) have the potential to experience display related issues. although the iabp continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the iabp on the information screen.
  • Action
    Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.

Device

Device Recall CS300 IntraAortic Balloon Pump
  • Model / Serial
    Product number 0998-00-3013-XX SN# SI126162D8 SI120003C8 SI122070C8 SI147171J8 SI124922D8 SI118561B8 SI121095C8 SI121099C8 SI122072C8 SI118566B8 SI119984C8 SI119986C8 SI119994C8 SI119997C8 SI120015C8 SI120021C8 SI120022C8 SI121087C8 SI119989C8 SI118559B8 SI119999C8 SI120000C8 SI120001C8 SI120005C8 SI120009C8 SI120017C8 SI121091C8 SI121100C8 SI124933D8 SI121090C8 SI120008C8 SI124911D8 SI124918D8 SI120004C8 SI120018C8 SI120020C8 SI121085C8 SI121097C8 SI121098C8 SI121103C8 SI121104C8 SI121107C8 SI121117C8 SI122075C8 SI120023C8 SI120019C8 SI121115C8 SI121119C8 SI122073C8 SI120006C8 SI120013C8 SI120014C8 SI121081C8 SI121082C8 SI121083C8 SI121094C8 SI121102C8. International: SI118567B8 SI118558B8 SI135828G8 SI118560B8 SI118565B8 SI119992C8 SI119987C8 SI119988C8 SI124910D8 SI135278G8 SI118562B8 SI119995C8 SI119985C8 SI118563B8 SI121084C8 S8119777B8 SI124923D8 SI121089C8 SI124939D8 SI124937D8 SI118564B8 SI124915D8 SI119991C8 SI119998C8 SI121096C8 SI158367D9  SI124920D8.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
  • Product Description
    CS300 Intra-Aortic Balloon Pump
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA