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
    102439
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-06
  • 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
    If the li-ion battery is accidently dropped the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions battery venting has the potential to create smoke a foul odor and sparks.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0800-XX (Lot serial: to Nov 2016); Model Catalog: 0998-00-0800-XX (Lot serial: ALL Li-Ion batteries); Model Catalog: 0998-00-0800-XX (Lot serial: distributed from Dec 2011)
  • Product Description
    CARDIOSAVE HYBRID AND RESCUE INTRA-AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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