Events

Recall of SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATASCOPE CORP..

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
    21773
  • Event Risk Class
    II
  • Event Initiated Date
    2000-05-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Sporadic field reports of intermittent failures with the safety vent valve test conducted during the power-up initialization and gave an electrical code #57 on the screen containing software revision c & b.

Device

SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0446-XX (Lot serial: S83000-H9 S83960-H9); Model Catalog: 0998-00-0446-XX (Lot serial: S82435-D9 S82441-D9); Model Catalog: 0998-00-0446-XX (Lot serial: AND S82463-E9.); Model Catalog: 0998-00-0446-XX (Lot serial: S/N: S81212-H8 S82964-H9)
  • Product Description
    SYSTEM 98 INTRA-AORTIC BALLOON PUMPS
  • Manufacturer
    DATASCOPE CORP.

Manufacturer

DATASCOPE CORP.
  • Manufacturer Address
    MAHWAH
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC