Events

Recall of Balloon pump

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    21730
  • Event Initiated Date
    2017-07-27
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    The manufacturer has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues:, " false blood detection alarm, and, " the ingress of fluids into the iabp affecting various electronic circuit boards., either issue could potentially prevent initiation or continuation of therapy.
  • Action
    Manufacturer to issue advice regarding use

Device

Balloon pump
  • Model / Serial
    Model: , Affected: CS100 and CS300 Intraortic Balloon Pumps, also applies to any System 98 or System 98XT IABP which was converted to a CS100i or CS300 IABP.
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA