• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—June 3

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    LEMO USA Inc.

    Halkey-Roberts Corporation

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Halkey-Roberts Corporation

    Cirtec Medical

    JBC Technologies

    Arthur G. Russell Co. Inc., The
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Recall: Intra-Aortic Balloon Pumps Carry Risk of Valve Failure

    The Datascope Corp./MAQUET valve failure could prevent balloon inflation and deflation.

    Recall: Intra-Aortic Balloon Pumps Carry Risk of Valve Failure
    Image of a Datascope Corp./MAQUET Intra-Aortic Balloon Pump
    U.S. Food and Drug Administration08.07.17
    The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death
     
    Recalled Product
    • Datascope Corp./MAQUET Intra-Aortic Balloon Pump
    • Model/Item Numbers: CS100i, CSO100, CS300
    • Lot Numbers: All Lots Manufactured Before June 30, 2013
    • Manufacturing Dates: July 22, 2003 to June 30, 2013
    • Distribution Dates: March 24, 2003 to December 11, 2013
    • Devices Recalled in the U.S.: 9,194
     
    Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.
     
    Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured before June 30, 2013 due to the risk of a valve failure which prevents the balloon from inflating and deflating properly. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
     
    On June 30, 2013, Datascope Corp./MAQUET implemented a design change to prevent this problem, but not all devices manufactured prior to June 13, 2013 have been serviced and upgraded.
     
    Who May Be Affected
    • Hospitals and health care professionals using a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured before June 30, 2013 and has not been serviced and upgraded by the manufacturer.
    • Patients receiving circulatory support with a Datascope Corp./MAQUET Intra-Aortic Balloon Pump that was manufactured before June 30, 2013.
     
    On June 19, 2017, Datascope Corp./MAQUET sent affected customers an "Urgent Product Recall Medical Device Field Correction" notice informing them of the device's risks, and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced. The firm recommends that the risks and benefits of using an affected CS100i, CS100, or CS300 IABP be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available.
     
    The notice directed customers to please adhere to the following instructions when using affected devices:
     
    • Check inventory to identify any affected IABP units that may be stored or are currently in use.
    • Pursuant to the User Instruction Warnings, health care providers are instructed not to leave a patient unattended during IABP therapy.
    • A service representative from Datascope will be replacing the defective solenoid driver boards. Customers with affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service.
    • Until the service is performed, Datascope recommends powering on the IABP prior to inserting the IAB catheter to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform.
    • In the event of a clinical emergency, health care providers should use a replacement IABP that has been serviced and upgraded, or an available alternative device.
    • In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.
    • Customers are instructed to complete and return the Medical Device Field Correction Response Form enclosed in the notice via fax to 1-973-807-9217, or email at: IABP2017@getinge.com.
    • If you are a distributor who has shipped any affected products to customers, please forward the Urgent Product Recall Medical Device Field Correction Notice to their attention for appropriate action.
     
    Customers with questions regarding this field correction may contact Datascope Corp./MAQUET's Customer Service Department at 1-(888)-627-8383 and press "2" (Monday through Friday from 8:00 a.m. to 6:00 p.m. EDT).
    Related Searches
    • design
    • Manufacturing
    • fda
    • medical
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    iCAD Signs Global Distribution Agreement With Sectra iCAD Signs Global Distribution Agreement With Sectra
    Receiving FDA Approval in Under One Month Receiving FDA Approval in Under One Month
    RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery
    Philips Recalls Certain Sleep and Respiratory Care Devices Philips Recalls Certain Sleep and Respiratory Care Devices
    Adopting a Data-Driven Quality Model Adopting a Data-Driven Quality Model
    Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems
    Penumbra Recalls JET 7 Reperfusion Catheter Over Distal Tip Damage Penumbra Recalls JET 7 Reperfusion Catheter Over Distal Tip Damage
    Quantitative Transmission Ultrasound Outperforms Mammography Quantitative Transmission Ultrasound Outperforms Mammography
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    Setting the Standard: Protective Nanocoatings for Today Setting the Standard: Protective Nanocoatings for Today's Medtech
    Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    The Top 30 and M&A in 2021: What’s Next? The Top 30 and M&A in 2021: What’s Next?
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device

    Related Breaking News

    • Digital Health
      iCAD Signs Global Distribution Agreement With Sectra

      iCAD Signs Global Distribution Agreement With Sectra

      Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.
      Globe Newswire 08.19.21

    • Contract Manufacturing
      Receiving FDA Approval in Under One Month

      Receiving FDA Approval in Under One Month

      How the team working on an “Open-Source” COVID Ambu-bot Ventilator optimized its short timeline.
      Aaron Burlew, Senior Applications Engineer, Teknic Inc. 07.06.21

    • Surgical
      RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery

      RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery

      The module automatically tracks and identifies surgical steps during procedures, providing the basis for intraoperative clinical decision support systems.
      RSIP Vision 06.17.21


    • Philips Recalls Certain Sleep and Respiratory Care Devices

      Philips Recalls Certain Sleep and Respiratory Care Devices

      Mitigates potential health risks related to the sound abatement foam component.
      GlobeNewswire 06.14.21

    • Software & IT
      Adopting a Data-Driven Quality Model

      Adopting a Data-Driven Quality Model

      Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.
      David Jensen, Staff Writer, MasterControl 04.09.21

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • MPO's Most-Read Stories This Week—June 3
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—June 3
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Color Street Celebrates Pride Month with Limited-Edition ‘Over the Rainbow’ Nail Strips
    Olay Rolls Out Sensitive Skin Line
    World Taste & Smell Association's June 6 Webinar Looks at Smell and Multisensory Design
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX Digital, hubergroup and HP Top This Week’s Stories
    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 3
    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Francisco Melo, Smart Skis, onsemi Top This Week’s Stories
    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login