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 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
    22884
  • Event Risk Class
    I
  • Event Initiated Date
    2017-07-19
  • 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
    Manufacturer has determined that condensation in the drain line tubing may lead to a false blood detection alarm activating when no blood is present. also liquid spills such as saline can create bridges of resistance between the circuit components causing the circuit not to function as intended. this can impact initiation or continuation of therapy.

Device

SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP
  • Model / Serial
    Model Catalog: 0998-00-0446-XX (Lot serial: S806023-D2); Model Catalog: 0998-00-0446-XX (Lot serial: S803570-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803551-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803492-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803634-C0); Model Catalog: 0998-00-0446-XX (Lot serial: S804566-L0); Model Catalog: 0998-00-0446-XX (Lot serial: S81995-A9); Model Catalog: 0998-00-0446-XX (Lot serial: S803567-B0); Model Catalog: 0998-00-3013-XX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0998-00-0446-XX (Lot serial: S803785-E0); Model Catalog: 0998-00-0446-XX (Lot serial: S803639-C0); Model Catalog: 0998-00-0479-XX (Lot serial: S806816-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S806811-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S805908-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S805907-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S81212-H8); Model Catalog: 0998-00-0479-XX (Lot serial: S804785-B1); Model Catalog: 0998-00-3023-53 (Lot serial:
  • Product Description
    SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;SYSTEM 98XT INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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