Events

Recall of CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    105480
  • Event Risk Class
    II
  • Event Initiated Date
    2011-03-24
  • 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
    The fan assembly of the power supply for certain system 98/98xt cs100/cs100i and cs300 iabps could potentially contain a misshapen retaining ring. this retaining ring could disengage within the fan causing the fan blade assembly to stop rotating. consequently the power supply would detect an overheating event and shut down without visual or audible alarms.

Device

CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 0998-00-3023-XX (Lot serial: S807282-E3); Model Catalog: 0998-00-3023-XX (Lot serial: SL135791GB); Model Catalog: 0998-00-3023-XX (Lot serial: SL15602-1C9); Model Catalog: 0998-00-3013-XX (Lot serial: SA04837-L5); Model Catalog: 0998-00-3013-XX (Lot serial: SA01419-A4)
  • Product Description
    CS300 INTRA AORTIC BALLOON PUMP SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC