Events

Recall of Device Recall CS100 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-1811-2010
  • 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=91454
  • 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 CS100 IntraAortic Balloon Pump.
  • Model / Serial
    Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.
  • 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
    CS100 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