Events

Recall of Device Recall Maquet CARDIOSAVE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Datascope Corp - Cardiac Assist Division.

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
    70510
  • Event Risk Class
    Class 2
  • Event Number
    Z-1140-2015
  • Event Initiated Date
    2015-01-30
  • Event Date Posted
    2015-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133942
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, balloon, intra-aortic and control - Product Code DSP
  • Reason
    Power supply malfunction complaints related to suboptimal thermal management.
  • Action
    Maquet Inc. sent a recall letter/return response form dated 1/30/2015.

Device

Device Recall Maquet CARDIOSAVE
  • Model / Serial
    0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55.   CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution
  • Product Description
    Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Manufacturer Address
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA