Events

Recall of Device Recall DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP CONTROL SYSTEM

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
    51178
  • Event Risk Class
    Class 2
  • Event Number
    Z-1198-2009
  • Event Initiated Date
    2009-02-04
  • Event Date Posted
    2009-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78911
  • 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
    Non-functioning cable: the low-level output cable when connected to a datascope intra-aortic ballon pump (iabp) and patient monitor does not provide a signal to the patient monitor.
  • Action
    An "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.

Device

Device Recall DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRAAORTIC BALLOON CATHETER AND CS300 IABP ...
  • Model / Serial
    Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- states of IL and FL.
  • Product Description
    Low-Level Output Cable. || The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
  • 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