• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    EchoNous Partners with Samsung

    Solid Growth Forecast for Global Ostomy Devices Market

    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility

    Respira Technologies Appoints Brian Quigley as CEO

    Nikki Troiano Gainey Joins RIVANNA Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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
    JBC Technologies

    Cirtec Medical

    Xact Wire EDM Corp.

    Concise Engineering

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Buyer and Seller Tips on Mergers & Acquisitions for MPO Companies

    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Cirtec Medical

    Xact Wire EDM Corp.

    Concise Engineering

    Fusion Biotec Inc.
    • 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

    Edwards Recalls Intra-Aortic Occlusion Device Over Balloon Rupture Risk

    The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass.

    Edwards Recalls Intra-Aortic Occlusion Device Over Balloon Rupture Risk
    Related CONTENT
    • iCAD Signs Global Distribution Agreement With Sectra
    • Contraline Expands Board of Directors
    • Royal Philips Enters Strategic Partnership with NICO.LAB
    • Receiving FDA Approval in Under One Month
    • RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery
    U.S. Food and Drug Administration07.02.19
    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
     
    • IntraClude Intra-Aortic Occlusion Device ICF100
    • Model: ICF100
    • UDI code (01) 00690103190007
    • Lots:
    • 60972890 61078031 61097633 61139239 61259627
    • 61259628 61713218 61723505 61898939
    • Distribution Dates:  May 1, 2017 to February 19, 2019
    • Devices Recalled in the U.S.: 757
    • Date Initiated by Firm:  May 14, 2019
     
    The IntraClude Intra-Aortic Occlusion device is used in patients undergoing cardiopulmonary bypass—a technique in which a machine temporarily takes over the function of the heart and lungs during surgery.
     
    When the IntraClude balloon is inflated, the device blocks and vents (occludes) the aorta so that the heart is assessed without interference of other organs.
     
    Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during use, which may add time to the procedure and compromises the safety of the patient.
     
    The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke, and death.
     
    The firm has received 22 complaints related to balloon rupture or puncture. Three deaths have been reported.
     
    Patients who undergo procedures involving the IntraClude Intra-Aortic Occlusion Device and healthcare providers, distributors, and facilities using it may be affected.
     
    On May 14, 2019, Edwards Lifesciences issued an Urgent Recall Notification sent to customers, listing the following actions:
     
    Customers
     
    • Review the field safety notice to understand the potential hazard.
    • Complete and return the attached Acknowledgement Form within five business days of receiving this notice to Customer Service via fax at (800) 422-9329 or email to cs.usfaxes@edwards.com
    • Complete and return the Product Reconciliation Form to Customer Service: Record the quantity of any of the listed lot numbers in your possession. Contact Customer Service to arrange return and replacement of affected devices and return affected devices to Edwards with the Return Goods Authorization (RGA) provided.
    • Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any balloon failures to Edwards Lifesciences.
    • Your assistance is appreciated and necessary to ensure that this notice is reviewed, and that the response forms and affected devices are returned promptly.
    Related Searches
    • fda
    • organs
    • ul
    • it
    Suggested For You
    iCAD Signs Global Distribution Agreement With Sectra iCAD Signs Global Distribution Agreement With Sectra
    Contraline Expands Board of Directors Contraline Expands Board of Directors
    Royal Philips Enters Strategic Partnership with NICO.LAB Royal Philips Enters Strategic Partnership with NICO.LAB
    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
    FDA Clears Neurescue FDA Clears Neurescue's Intelligent Balloon Catheter
    Abiomed Buys preCARDIA, a Heart Failure Tech Firm Abiomed Buys preCARDIA, a Heart Failure Tech Firm
    Medtronic Receives FDA Approval for Pipeline Flex Embolization Device with Shield Technology Medtronic Receives FDA Approval for Pipeline Flex Embolization Device with Shield Technology
    Acutus Medical Receives FDA Clearance of AcQCross Acutus Medical Receives FDA Clearance of AcQCross
    BD Receives 510(k) Clearance for Pristine Catheter BD Receives 510(k) Clearance for Pristine Catheter
    Medtronic Introduces Extended Infusion Set in Europe Medtronic Introduces Extended Infusion Set in Europe
    Adopting a Data-Driven Quality Model Adopting a Data-Driven Quality Model
    CSI Buys Peripheral Support Catheters from WavePoint Medical CSI Buys Peripheral Support Catheters from WavePoint Medical
    Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

    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

    • Contraline Expands Board of Directors

      Contraline Expands Board of Directors

      Medical device industry veteran Martin J. Emerson has joined the company's board.
      Business Wire 07.09.21

    • Neurological
      Royal Philips Enters Strategic Partnership with NICO.LAB

      Royal Philips Enters Strategic Partnership with NICO.LAB

      Advances its commitment to improving outcomes for people who suffer a stroke.
      Philips 07.08.21


    • 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

    Loading, Please Wait..

    Trending
    • Monkeypox Outbreak Driving New IVD Device Development
    • M1 MedTech Announces Fall 2022 Cohort
    • Preceptis Medical’s Tympanostomy Tube System Cleared For Expanded Indications
    • Pulsed Field Ablation Tech Gaining Popularity
    • Edwards' PASCAL Precision Gains EU Nod
    Breaking News
    • EchoNous Partners with Samsung
    • Solid Growth Forecast for Global Ostomy Devices Market
    • KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    • Respira Technologies Appoints Brian Quigley as CEO
    • Nikki Troiano Gainey Joins RIVANNA Board
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends
    Icon Foods Appoints Operations and Marketing Leaders
    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD
    Coatings World

    Latest Breaking News From Coatings World

    Birla Carbon, NREL Collaboration to be Presented at ACS Conference
    Coating Resins Market Worth $70.9 Billion by 2027: MarketsandMarkets
    PPG Appoints Brad Budde Vice President and Chief Digital Officer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Partners with Samsung
    Solid Growth Forecast for Global Ostomy Devices Market
    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    GRAM to Fill and Finish Smallpox/Monkeypox Vaccines
    bluebird bio Wins FDA Approval of ZYNTEGLO
    Pace Life Sciences Acquires Meridian BioGroup
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Sephora at Kohl’s to Expand Sephora Presence to All 1,100+ Kohl’s Locations
    Emma Watson to Front New Fragrance Campaign for Prada
    The Estée Lauder Companies Delivers Strong Results in Fiscal 2022
    Happi

    Latest Breaking News From Happi

    Amorepacific, MIT Develop World's First Chip-less Wireless Electronic Skin Enabled by Semiconductors
    Maesa Launches Itk Skincare with TikTok Stars Brooklyn and Bailey McKnight
    Skin Delivery Formulation
    Ink World

    Latest Breaking News From Ink World

    Xeikon to Introduce TITON Food-Safe Dry-Toner Technology at Labelexpo Americas 2022
    Smurfit Kappa Employees Charity Cycle Across Europe
    ProAmpac’s Rocky Mount, VA Facility Receives ISCC Plus Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ePac makes big announcement, Avery Dennison debuts new technology and more
    Techkon USA announces latest handheld spectrodensitometer
    Maxcess China now manufacturing solid dies in Huzhou
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Appoints Director of Membership and Industry Relations
    Nexwear Acquires Incontinence Products Brand Lily Bird
    Because Market Expands into Retail Stores
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Theragen Receives Patent for Spine Fusion Bone Growth Stimulator System
    Study: BONESUPPORT’s CERAMENT G Can Help Save Infected Limbs
    Zavation’s Cervical Intervertebral Body Fusion Device Cleared by FDA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL, Birla Carbon Collaboration to be Shown at ACS Conference
    ORNL Celebrates Launch of Frontier, the World’s Fastest Supercomputer
    DuPont Names 2022 Lavoisier and Pedersen Award Medalists

    Copyright © 2022 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