Events

Recall of Device Recall 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
    76052
  • Event Risk Class
    Class 2
  • Event Number
    Z-1386-2017
  • Event Initiated Date
    2016-12-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152101
  • 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
    Maquet has received 3 confirmed complaints related to the li-lon battery used with the maquet cardiosave hybrid iabp and maquet cardiosave rescue iabp of the battery venting after being accidentally dropped.
  • Action
    Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to cardiosavebattery@getinge.com

Device

Device Recall Cardiosave
  • Model / Serial
    part number 0146-00-0097
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX || Li-Ion Battery affected part number is 0146-00-0097 || Product Usage: || The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
  • 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