Events

Recall of Device Recall CARDIOSAVE Hybrid Intraaortic Balloon Pump (IABP)

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
    80003
  • Event Risk Class
    Class 1
  • Event Number
    Z-1928-2018
  • Event Initiated Date
    2018-05-03
  • 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=164199
  • 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
    Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
  • Action
    Notification of the field correction was posted to the firm's website on 5/3/18 at https://www.maquet.com/globalassets/downloads/product-articles/cardiosave/ml_0730_us_rev_a_cardiosave_fluid_ingress_recall_customer_letter_us_4may2018.pdf. Mailed notification letters will be issued to customers as well. The instructions included in the notification includes the following: Patients receiving IABP therapy are in critical condition. Failure to start or sudden interruption of therapy could result in unsafe, hemodynamic instability. Until the protective top cover is installed, please adhere to the following instructions when using Cardiosave intra-aortic balloon pump: 1) Pursuant to the Caution section of our Cardiosave IABP Operating/User Instructions, Never place fluids on top of this unit. Make sure that the saline container and tubing do not hang directly over the IABP. In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists In the unlikely event that a sudden interruption of therapy occurs, transfer the patient to an alternative IABP. The Intra-Aortic Balloon (IAB) Catheter Instructions for Use reiterates that a catheter should not remain inactive for more than 30 minutes, due to the potential for thrombus formation. If an alternative IABP is unavailable; manually inflate the IAB with air or helium and immediately aspirate, repeat every 5 minutes until either an alternate IABP is available or alternatively, the intra-aortic balloon catheter should be removed from the patient. Please refer to the intra-aortic balloon catheter instructions for use, Manually Inflating and Deflating a Catheter. The patient should be treated according to your facilitys treatment protocols and caregivers clinical judgment to ensure hemodynamic stability. Affected customers will be contacted by a Maquet/Getinge representative to schedule on-site service of your Cardiosave IABP by a Maquet/ Getinge Sales or Service Re

Device

Device Recall CARDIOSAVE Hybrid Intraaortic Balloon Pump (IABP)
  • Model / Serial
    All Serial Numbers distributed from 03/06/2012 to 04/26/2018
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam. The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.
  • Product Description
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
  • 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