Events

Recall of CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

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
    103412
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-04
  • 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
    Since the commencement of commercialization of the cardiosave hybrid intra-aortic balloon pumps (iabp) in december 2011 maquet has received thirteen (13) power supply complaints that were determined to be related to suboptimal thermal management. it is important to note that none of the thirteen complaints identified any adverse patient events. suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the cardiosave hybrid iabp console and the inability to charge the batteries. failure to provide the correct output voltage to the console will result in the unit not functioning from ac power even when plugged into an active electrical outlet. should a power supply malfunction occur an on screen message will alert the healthcare provider that the cardiosave hybrid iabp unit is operating on battery power.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0800-XX (Lot serial: CA221162L2); Model Catalog: 0998-00-0800-XX (Lot serial: CA222640A3); Model Catalog: 0998-00-0800-XX (Lot serial: CA216325I2); Model Catalog: 0998-00-0800-XX (Lot serial: CA237421K3); Model Catalog: 0998-00-0800-XX (Lot serial: CA221164L2)
  • Product Description
    MAQUET CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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